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| Sponsor: | Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00388882 |
Purpose
The objective of this study is to evaluate the efficacy and safety of 12 weeks treatment with tiotro pium HandiHaler® 18 mcg daily compared to Combivent® MDI CFC Inhalation Aerosol 2 actuations qid in COPD patients currently prescribed Combivent® MDI.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: tiotropium Drug: ipratropium bromide / albuterol |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Randomized, Double-blind, Parallel Group Trial Comparing 12 Weeks Treatment With Tiotropium 18 Mcg Daily With Combivent MDI 2 Actuations Qid |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Arizona | |
| 205.346.107 Boehringer Ingelheim Investigational Site | |
| Phoenix, Arizona, United States | |
| United States, California | |
| 205.346.101 Boehringer Ingelheim Investigational Site | |
| Torrance, California, United States | |
| 205.346.104 Boehringer Ingelheim Investigational Site | |
| Lakewood, California, United States | |
| 205.346.108 Boehringer Ingelheim Investigational Site | |
| Sepulveda, California, United States | |
| United States, Colorado | |
| 205.346.106 Boehringer Ingelheim Investigational Site | |
| Wheat Ridge, Colorado, United States | |
| United States, Idaho | |
| 205.346.102 Boehringer Ingelheim Investigational Site | |
| Couer d'Alene, Idaho, United States | |
| United States, Louisiana | |
| 205.346.109 Boehringer Ingelheim Investigational Site | |
| Shreveport, Louisiana, United States | |
| United States, Pennsylvania | |
| 205.346.110 Boehringer Ingelheim Investigational Site | |
| Philadelphia, Pennsylvania, United States | |
| United States, South Carolina | |
| 205.346.103 Boehringer Ingelheim Investigational Site | |
| Spartanburg, South Carolina, United States | |
| 205.346.105 Boehringer Ingelheim Investigational Site | |
| Charleston, South Carolina, United States | |
| Argentina | |
| 205.346.502 | |
| Buenos Aires, Argentina | |
| 205.346.503 | |
| Buenos Aires, Argentina | |
| 205.346.504 Instituto de Patologías Respiratorias | |
| San Miguel de Tucumán, Argentina | |
| 205.346.505 | |
| Mendoza, Argentina | |
| 205.346.508 | |
| Buenos Airess, Argentina | |
| 205.346.509 | |
| Rosario, Santa Fe, Argentina | |
| 205.346.510 | |
| Bs As, Argentina | |
| 205.346.511 | |
| Rosario, Santa Fé, Argentina | |
| Lithuania | |
| 205.346.401 Boehringer Ingelheim Investigational Site | |
| Alytus, Lithuania | |
| 205.346.402 Boehringer Ingelheim Investigational Site | |
| Vilnius, Lithuania | |
| 205.346.404 Boehringer Ingelheim Investigational Site | |
| Kaunas, Lithuania | |
| 205.346.405 Boehringer Ingelheim Investigational Site | |
| Kaunas, Lithuania | |
| 205.346.406 Boehringer Ingelheim Investigational Site | |
| Vilnius, Lithuania | |
| 205.346.407 Boehringer Ingelheim Investigational Site | |
| Vilnius, Lithuania | |
| 205.346.408 Boehringer Ingelheim Investigational Site | |
| Utena, Lithuania | |
| 205.346.409 Boehringer Ingelheim Investigational Site | |
| Siauliai, Lithuania | |
| 205.346.411 Boehringer Ingelheim Investigational Site | |
| Klaipeda, Lithuania | |
| Slovakia | |
| 205.346.301 Boehringer Ingelheim Investigational Site | |
| Kosice, Slovakia | |
| 205.346.302 Boehringer Ingelheim Investigational Site | |
| Bratislava, Slovakia | |
| 205.346.303 Boehringer Ingelheim Investigational Site | |
| Levica, Slovakia | |
| 205.346.304 Boehringer Ingelheim Investigational Site | |
| Lucenec, Slovakia | |
| 205.346.305 Boehringer Ingelheim Investigational Site | |
| Bratislava, Slovakia | |
| 205.346.306 Boehringer Ingelheim Investigational Site | |
| Sturovo, Slovakia | |
| United Kingdom | |
| 205.346.201 Boehringer Ingelheim Investigational Site | |
| Nottingham, United Kingdom | |
| 205.346.203 Boehringer Ingelheim Investigational Site | |
| Greenisland, United Kingdom | |
| 205.346.209 Boehringer Ingelheim Investigational Site | |
| Swansea, United Kingdom | |
| 205.346.205 Boehringer Ingelheim Investigational Site | |
| Windsor, United Kingdom | |
| 205.346.206 Boehringer Ingelheim Investigational Site | |
| Westbury on Trym, United Kingdom | |
| 205.346.207 Boehringer Ingelheim Investigational Site | |
| Soham, United Kingdom | |
| 205.346.204 Boehringer Ingelheim Investigational Site | |
| Aylesbury, United Kingdom | |
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
More Information
| Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
| Study ID Numbers: | 205.346, EudraCT 2006-000822-30 |
| Study First Received: | October 16, 2006 |
| Last Updated: | September 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00388882 History of Changes |
| Health Authority: | Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnología); Great Britain: MHRA; Lithuania: State Medicines Control Agency, LT-01132 Vilnius; Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26; United States: Food and Drug Administration |
|
Parasympatholytics Respiratory System Agents Neurotransmitter Agents Disease Attributes Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents Cholinergic Agents Pharmacologic Actions Lung Diseases, Obstructive |
Pathologic Processes Respiratory Tract Diseases Ipratropium Autonomic Agents Therapeutic Uses Lung Diseases Chronic Disease Peripheral Nervous System Agents Tiotropium Bronchodilator Agents Pulmonary Disease, Chronic Obstructive |