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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00523991 |
Purpose
A 24 week, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of 18mcg of tiotropium inhalation capsules administered by Handihaler once daily plus PRN albuterol (salbutamol) vs. placebo plus PRN albuterol (salbutamol) in chronic obstructive pulmonary disease subjects naive to maintenance therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium inhalation capsules |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 24 Week, Randomized, Double-blind, Placebo Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 18 MCG of Tiotropium Inhalation Capsules Administered by HandiHaler Once-daily Plus PRN Albuterol (Salbutamol) vs. Placebo Plus PRN Albuterol (Salbutamol) in Chronic Obstructive Pulmonary Disease Subjects Naive to Maintenance Therapy |
| Estimated Enrollment: | 436 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Boehringer Ingelheim Study Coordinator | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Hide Study Locations| United States, Alabama | |
| 205.365.1003 Boehringer Ingelheim Investigational Site | Completed |
| Birmingham, Alabama, United States | |
| 205.365.1004 Boehringer Ingelheim Investigational Site | Completed |
| Birmingham, Alabama, United States | |
| 205.365.1098 Boehringer Ingelheim Investigational Site | Recruiting |
| Jasper, Alabama, United States | |
| United States, California | |
| 205.365.1023 Boehringer Ingelheim Investigational Site | Completed |
| Palo Alto, California, United States | |
| 205.365.1125 Boehringer Ingelheim Investigational Site | Recruiting |
| San Diego, California, United States | |
| United States, Florida | |
| 205.365.1101 Boehringer Ingelheim Investigational Site | Recruiting |
| Chiefland, Florida, United States | |
| 205.365.1102 Boehringer Ingelheim Investigational Site | Recruiting |
| Spring Hill, Florida, United States | |
| United States, Kentucky | |
| 205.365.1024 Boehringer Ingelheim Investigational Site | Recruiting |
| Lexington, Kentucky, United States | |
| United States, Maryland | |
| 205.365.1012 Boehringer Ingelheim Investigational Site | Recruiting |
| Baltimore, Maryland, United States | |
| United States, Minnesota | |
| 205.365.1006 Boehringer Ingelheim Investigational Site | Recruiting |
| Rochester, Minnesota, United States | |
| 205.365.1086 Boehringer Ingelheim Investigational Site | Recruiting |
| Bloomington, Minnesota, United States | |
| United States, Nebraska | |
| 205.365.1085 Boehringer Ingelheim Investigational Site | Recruiting |
| Omaha, Nebraska, United States | |
| United States, New Mexico | |
| 205.365.1010 Boehringer Ingelheim Investigational Site | Completed |
| Albuquerque, New Mexico, United States | |
| United States, New York | |
| 205.365.1007 Boehringer Ingelheim Investigational Site | Recruiting |
| Rochester, New York, United States | |
| United States, North Carolina | |
| 205.365.1080 Boehringer Ingelheim Investigational Site | Recruiting |
| Charlotte, North Carolina, United States | |
| United States, Ohio | |
| 205.365.1118 Boehringer Ingelheim Investigational Site | Recruiting |
| Cincinnati, Ohio, United States | |
| United States, Pennsylvania | |
| 205.365.1033 Boehringer Ingelheim Investigational Site | Recruiting |
| Pittsburgh, Pennsylvania, United States | |
| United States, Tennessee | |
| 205.365.1092 Boehringer Ingelheim Investigational Site | Recruiting |
| Kingsport, Tennessee, United States | |
| United States, West Virginia | |
| 205.365.1122 Boehringer Ingelheim Investigational Site | Recruiting |
| Clarksburg, West Virginia, United States | |
| Belgium | |
| 205.365.1103 Boehringer Ingelheim Investigational Site | Recruiting |
| Gilly, Belgium | |
| 205.365.1057 Boehringer Ingelheim Investigational Site | Recruiting |
| Menen, Belgium | |
| 205.365.1058 Boehringer Ingelheim Investigational Site | Recruiting |
| Yvoir, Belgium | |
| 205.365.1059 Boehringer Ingelheim Investigational Site | Recruiting |
| Leuven, Belgium | |
| Canada, British Columbia | |
| 205.365.1042 Boehringer Ingelheim Investigational Site | Terminated |
| Vancouver, British Columbia, Canada | |
| Canada, Ontario | |
| 205.365.1056 Boehringer Ingelheim Investigational Site | Terminated |
| Kingston, Ontario, Canada | |
| 205.365.1104 Boehringer Ingelheim Investigational Site | Recruiting |
| Toronto, Ontario, Canada | |
| Canada, Quebec | |
| 205.365.1041 Boehringer Ingelheim Investigational Site | Completed |
| Ste-Foy, Quebec, Canada | |
| Czech Republic | |
| 205.365.1061 Boehringer Ingelheim Investigational Site | Completed |
| Karlovy Vary, Czech Republic | |
| 205.365.1075 Boehringer Ingelheim Investigational Site | Recruiting |
| Strakonice, Czech Republic | |
| 205.365.1079 Boehringer Ingelheim Investigational Site | Terminated |
| Neratovice, Czech Republic | |
| 205.365.1077 Boehringer Ingelheim Investigational Site | Recruiting |
| Liberec, Czech Republic | |
| 205.365.1062 Boehringer Ingelheim Investigational Site | Recruiting |
| Praha 10, Czech Republic | |
| 205.365.1063 Boehringer Ingelheim Investigational Site | Recruiting |
| Tabor, Czech Republic | |
| 205.365.1064 Boehringer Ingelheim Investigational Site | Recruiting |
| Cvikov, Czech Republic | |
| 205.365.1076 Boehringer Ingelheim Investigational Site | Recruiting |
| Usti Nad Labem, Czech Republic | |
| 205.365.1117 Boehringer Ingelheim Investigational Site | Recruiting |
| Praha 6, Czech Republic | |
| 205.365.1107 Boehringer Ingelheim Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic | |
| 205.365.1116 Boehringer Ingelheim Investigational Site | Recruiting |
| Pardubice, Czech Republic | |
| 205.365.1083 Boehringer Ingelheim Investigational Site | Completed |
| Praha 3, Czech Republic | |
| Germany | |
| 205.365.1050 Boehringer Ingelheim Investigational Site | Recruiting |
| Ulm, Germany | |
| 205.365.1052 Boehringer Ingelheim Investigational Site | Recruiting |
| Rüdersdorf, Germany | |
| 205.365.1054 Boehringer Ingelheim Investigational Site | Completed |
| Gelnhausen, Germany | |
| 205.365.1055 Boehringer Ingelheim Investigational Site | Recruiting |
| Berlin, Germany | |
| 205.365.1066 Boehringer Ingelheim Investigational Site | Completed |
| Berlin, Germany | |
| Greece | |
| 205.365.1067 Boehringer Ingelheim Investigational Site | Recruiting |
| Athens, Greece | |
| Netherlands | |
| 205.365.1069 Boehringer Ingelheim Investigational Site | Recruiting |
| Zutphen, Netherlands | |
| 205.365.1070 Boehringer Ingelheim Investigational Site | Recruiting |
| Enschede, Netherlands | |
| 205.365.1071 Boehringer Ingelheim Investigational Site | Recruiting |
| Spijkenisse, Netherlands | |
| 205.365.1072 Boehringer Ingelheim Investigational Site | Completed |
| Etten Leur, Netherlands | |
| Portugal | |
| 205.365.1020 Boehringer Ingelheim Investigational Site | Recruiting |
| Coimbra, Portugal | |
| 205.365.1022 Boehringer Ingelheim Investigational Site | Recruiting |
| Lisboa, Portugal | |
| 205.365.1025 Boehringer Ingelheim Investigational Site | Recruiting |
| Amadora, Portugal | |
| Ukraine | |
| 205.365.1108 Boehringer Ingelheim Investigational Site | Recruiting |
| Kharkov, Ukraine | |
| 205.365.1110 Boehringer Ingelheim Investigational Site | Recruiting |
| Kharkiv, Ukraine | |
| 205.365.1112 Boehringer Ingelheim Investigational Site | Recruiting |
| Kharkov, Ukraine | |
| 205.365.1113 Boehringer Ingelheim Investigational Site | Recruiting |
| Simferopol, Ukraine | |
| 205.365.1114 Boehringer Ingelheim Investigational Site | Recruiting |
| Kiev, Ukraine | |
| 205.365.1115 Boehringer Ingelheim Investigational Site | Recruiting |
| Kiev, Ukraine | |
| 205.365.1128 Boehringer Ingelheim Investigational Site | Recruiting |
| Dnipropetrovsk, Ukraine | |
| United Kingdom | |
| 205.365.44004 Boehringer Ingelheim Investigational Site | Terminated |
| Warminster, United Kingdom | |
| 205.365.44003 Boehringer Ingelheim Investigational Site | Terminated |
| Harrow, United Kingdom | |
| 205.365.44002 Boehringer Ingelheim Investigational Site | Recruiting |
| Garston, Watford, United Kingdom | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 205.365, 2006-006276-38 A4471008 |
| Study First Received: | July 9, 2007 |
| Last Updated: | November 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00523991 History of Changes |
| Health Authority: | Belgium: Federal Agency for Medicines and Health Products; Canada: Health Canada - Therapeutic Products Directorate; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; Germany: Federal Institute for Drugs and Medical Devices; Great Britain: MHRA; Greece: National Organization of Medicines (EOF); Netherlands: Central Committee on Research involving Human Subjects (CCMO); Portugal: National Pharmacy and Medicines Institute; Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine); United States: Food and Drug Administration |
|
Respiratory System Agents Parasympatholytics Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Respiration Disorders Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions |
Lung Diseases, Obstructive Pathologic Processes Respiratory Tract Diseases Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |