Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00830102
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2009-01-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone 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'}]}, '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']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'dispFirstSubmitDate': '2011-06-08', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-08', 'studyFirstSubmitDate': '2009-01-26', 'dispFirstSubmitQcDate': '2011-06-08', 'studyFirstSubmitQcDate': '2009-01-26', 'dispFirstPostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-06-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Actual FEV1, % change from Baseline in Actual FEV1, change from Baseline in FEV1 % predicted normal, FEV1 max and FEV1 AUC above the Baseline', 'timeFrame': 'pre-dose and at 5, 15, 30, 45, 60, 90 minutes and 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Treatment-emergent AEs, clinical laboratory data, 12-lead ECGs and vital signs', 'timeFrame': '10 weeks including pre- and post-study assessments'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mild to Moderate Asthma'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'The primary purpose was to evaluate the efficacy of SKP FlutiForm HFA MDI compared to placebo or fluticasone and formoterol administered concurrently or alone in asthma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', '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* Smoking history within the last 12 months\n* No history of respiratory tract infection within 4 weeks\n* No history or evidence of any clinically significant disease or abnormality'}, 'identificationModule': {'nctId': 'NCT00830102', 'briefTitle': 'Single-dose Crossover Study to Compare the Safety and Efficacy of FlutiForm With Fluticasone and Formoterol Concurrently or Alone in Asthma Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'SkyePharma AG'}, 'officialTitle': 'A Randomized, Placebo-controlled, Double-blind, Six-way Crossover, Single-dose Exposure Study to Compare the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™100/10μg and 250/10μg) in a Single Inhaler (SkyePharma HFA MDI) With the Administration of Fluticasone (250μg) and Formoterol (12μg) Concurrently or Alone in Patients With Asthma', 'orgStudyIdInfo': {'id': 'SKY2028-2-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '* Period 1 Treatment Regimen A: FlutiForm 100/10 ug\n* Period 2 Treatment Regimen B: FlutiForm 250/10 ug\n* Period 3 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug\n* Period 4 Treatment Regimen D: Flixotide Evohaler 250 ug', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': '* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug\n* Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug\n* Period 3 Treatment Regimen B: FlutiForm 250/10 ug\n* Period 4 Treatment Regimen A: FlutiForm 100/10 ug', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': '* Period 1 Treatment Regimen B: FlutiForm 250/10 ug\n* Period 2 Treatment Regimen A: FlutiForm 100/10 ug\n* Period 3 Treatment Regimen F: Placebo\n* Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '4', 'description': '* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug\n* Period 2 Treatment Regimen F: Placebo\n* Period 3 Treatment Regimen A: FlutiForm 100/10 ug\n* Period 4 Treatment Regimen B: FlutiForm 250/10 ug', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '5', 'description': '* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug\n* Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug\n* Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug\n* Period 4 Treatment Regimen F: Placebo', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': '6', 'description': '* Period 1 Treatment Regimen F: Placebo\n* Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug\n* Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug\n* Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug', 'interventionNames': ['Drug: fluticasone propionate, formoterol fumarate']}], 'interventions': [{'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol 12 ug)\n* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI\n* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)\n* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)', 'armGroupLabels': ['1']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation)\n* Period 2 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)\n* Period 3 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)\n* Period 4 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)', 'armGroupLabels': ['2']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)\n* Period 2 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)\n* Period 3 Treatment Regimen F: Placebo (Two actuations of placebo HFA pMDI)\n* Period 4 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)', 'armGroupLabels': ['3']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)\n* Period 2 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)\n* Period 3 Treatment Regimen A: FlutiForm 100/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 50/5 ug/actuation)\n* Period 4 Treatment Regimen B: FlutiForm 250/10 ug (Two actuations of fluticasone/formoterol HFA pMDI 125/5 ug/actuation)', 'armGroupLabels': ['4']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)\n* Period 2 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA pMDI 125 ug/actuation)\n* Period 3 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)\n* Period 4 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI)', 'armGroupLabels': ['5']}, {'name': 'fluticasone propionate, formoterol fumarate', 'type': 'DRUG', 'otherNames': ['FlutiForm'], 'description': '* Period 1 Treatment Regimen F: Placebo (Two actuations of Placebo HFA pMDI\n* Period 2 Treatment Regimen E: Foradil Aerolizer 12 ug (One inhalation of formoterol DPI 12 ug)\n* Period 3 Treatment Regimen D: Flixotide Evohaler 250 ug (Two actuations of fluticasone HFA MDI 125 ug)\n* Period 4 Treatment Regimen C: Flixotide Evohaler 250 ug + Foradil Aerolizer 12 ug (Two actuations of fluticasone HFA pMDI 125ug/actuation and one inhalation of formoterol DPI 12ug/inhalation)', 'armGroupLabels': ['6']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Belfast', 'country': 'Ireland', 'facility': 'Investigational site'}, {'city': 'Derbyshire', 'country': 'United Kingdom', 'facility': 'Investigational site'}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'Manchester', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}, {'city': 'Plymouth', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 50.37153, 'lon': -4.14305}}, {'city': 'Slough', 'country': 'United Kingdom', 'facility': 'Investigational site', 'geoPoint': {'lat': 51.50949, 'lon': -0.59541}}], 'overallOfficials': [{'name': 'SKP', 'role': 'STUDY_DIRECTOR', 'affiliation': 'SkyePharma AG'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SkyePharma AG', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'SkyePharma AG', 'oldOrganization': 'SkyePharma AG'}}}}