Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-01-04 @ 3:46 AM
Study NCT ID:
NCT00535366
Status:
COMPLETED
Last Update Posted:
2014-05-30
First Post:
2007-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069447', 'term': 'Tiotropium Bromide'}, {'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068298', 'term': 'Fluticasone'}], 'ancestors': [{'id': 'D012602', 'term': 'Scopolamine Derivatives'}, {'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 103}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'dispFirstSubmitDate': '2014-04-30', 'lastUpdateSubmitDate': '2014-05-22', 'studyFirstSubmitDate': '2007-09-25', 'dispFirstSubmitQcDate': '2014-05-22', 'studyFirstSubmitQcDate': '2007-09-25', 'dispFirstPostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2014-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Trough FEV1 response at the end of each 4 week period of randomised treatment', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': 'Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}, {'measure': 'All adverse events', 'timeFrame': '24 weeks'}, {'measure': 'Pulse rate and blood pressure (seated)', 'timeFrame': '24 weeks'}, {'measure': 'FEV1 and FVC morning peak response', 'timeFrame': 'day 1 and day 28 of each blinded treatment'}, {'measure': 'FEV1 and FVC evening peak response', 'timeFrame': 'day 1 and day 28 of each blinded treatment'}, {'measure': 'FEV1 AUC (0-3h), after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}, {'measure': 'FEV1 AUC (12-15h) after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}, {'measure': 'FVC AUC (0-3h) after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}, {'measure': 'FVC AUC (12-15h) after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}, {'measure': 'Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period', 'timeFrame': 'day 1 and day 28 of each blinded treatment'}, {'measure': 'Weekly mean pre-dose morning and evening peak expiratory flow (PEF)', 'timeFrame': '28 weeks'}, {'measure': 'Weekly mean number of occasions of rescue therapy used per day', 'timeFrame': '28 weeks'}, {'measure': 'Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period', 'timeFrame': '28 weeks'}, {'measure': 'Fractional exhaled nitric oxide after 4 weeks of each blinded treatment', 'timeFrame': 'after 4 weeks of each blinded treatment'}]}, 'conditionsModule': {'conditions': ['Pulmonary Disease, Chronic Obstructive']}, 'descriptionModule': {'briefSummary': 'This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Relatively stable, moderate to severe COPD\n* Male or female patients 40 years of age or older.\n* Current or ex-smokers with a smoking history of more than 10 pack years\n\nExclusion Criteria:\n\n* Other significant disease that can influence the study results or be a safety risk for the patient\n* Other medication that can influence the study results\n* Hypersensitivity to the study medication\n* Patients with unstable COPD'}, 'identificationModule': {'nctId': 'NCT00535366', 'briefTitle': 'Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.', 'orgStudyIdInfo': {'id': '1249.1'}, 'secondaryIdInfos': [{'id': 'Eudract2007-003169-42'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tiotropium+salmeterol+fluticasone', 'interventionNames': ['Drug: Tiotropium', 'Drug: Salmeterol', 'Drug: Fluticasone']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium+salmeterol+ciclesonide low', 'interventionNames': ['Drug: Tiotropium', 'Drug: Salmeterol', 'Drug: Ciclesonide low']}, {'type': 'EXPERIMENTAL', 'label': 'Tiotropium+salmeterol+ciclesonide high', 'interventionNames': ['Drug: Tiotropium', 'Drug: Salmeterol', 'Drug: Ciclesonide high']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Tiotropium', 'Drug: Salmeterol', 'Drug: Placebo']}], 'interventions': [{'name': 'Tiotropium', 'type': 'DRUG', 'description': 'Oral inhalation by HandiHaler® device', 'armGroupLabels': ['Placebo', 'Tiotropium+salmeterol+ciclesonide high', 'Tiotropium+salmeterol+ciclesonide low', 'Tiotropium+salmeterol+fluticasone']}, {'name': 'Salmeterol', 'type': 'DRUG', 'description': 'Oral inhalation from Diskus®', 'armGroupLabels': ['Placebo', 'Tiotropium+salmeterol+ciclesonide high', 'Tiotropium+salmeterol+ciclesonide low', 'Tiotropium+salmeterol+fluticasone']}, {'name': 'Fluticasone', 'type': 'DRUG', 'description': 'Oral inhalation from metered dose inhaler (MDI)', 'armGroupLabels': ['Tiotropium+salmeterol+fluticasone']}, {'name': 'Ciclesonide low', 'type': 'DRUG', 'description': 'Oral inhalation from MDI', 'armGroupLabels': ['Tiotropium+salmeterol+ciclesonide low']}, {'name': 'Ciclesonide high', 'type': 'DRUG', 'description': 'Oral inhalation from MDI', 'armGroupLabels': ['Tiotropium+salmeterol+ciclesonide high']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral inhalation from MDI', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genk', 'country': 'Belgium', 'facility': '1249.1.32003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Ghent', 'country': 'Belgium', 'facility': '1249.1.32001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Hasselt', 'country': 'Belgium', 'facility': '1249.1.32002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'city': 'Ostend', 'country': 'Belgium', 'facility': '1249.1.32004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.21551, 'lon': 2.927}}, {'city': 'Aarhus C', 'country': 'Denmark', 'facility': '1249.1.45001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}, {'city': 'Großhansdorf', 'country': 'Germany', 'facility': '1249.1.49001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 53.66528, 'lon': 10.28552}}, {'city': 'Mannheim', 'country': 'Germany', 'facility': '1249.1.49002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.4891, 'lon': 8.46694}}, {'city': 'Weinheim', 'country': 'Germany', 'facility': '1249.1.49003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 49.54887, 'lon': 8.66697}}, {'city': 'Eindhoven', 'country': 'Netherlands', 'facility': '1249.1.31002 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.44083, 'lon': 5.47778}}, {'city': 'Harderwijk', 'country': 'Netherlands', 'facility': '1249.1.31003 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 52.34167, 'lon': 5.62083}}, {'city': 'Heerlen', 'country': 'Netherlands', 'facility': '1249.1.31001 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 50.88365, 'lon': 5.98154}}, {'city': 'Veldhoven', 'country': 'Netherlands', 'facility': '1249.1.31004 Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 51.41833, 'lon': 5.40278}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Boehringer Ingelheim, Study Chair', 'oldOrganization': 'Boehringer Ingelheim'}}}}