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| Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
|---|---|
| Information provided by: | Boehringer Ingelheim Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00239473 |
Purpose
The primary objective was to compare the bronchodilator efficacy of two doses (5 mcg and 10 mcg) of tiotropium inhalation solution delivered by the Respimat inhaler once daily to placebo and to ipratropium bromide MDI four times daily in patients with COPD. The secondary objective was to compare the safety of tiotropium inhalation solution delivered by the Respimat to placebo and ipratropium bromide MDI.
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Device: 5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler Device: 10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment |
| Official Title: | A Randomized, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses (5 Mcg and 10 Mcg) of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) i |
| Estimated Enrollment: | 336 |
| Study Start Date: | November 2002 |
| Estimated Study Completion Date: | September 2004 |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
Contacts and Locations| Germany | |
| Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany | |
| Boehringer Ingelheim Investigational Site | |
| München, Germany | |
| Inamed Research GmbH & Co. KG | |
| Gauting, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Bonn, Germany | |
| Universitätsklinikum Schleswig-Holstein | |
| Kiel, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Steinfurt, Germany | |
| MEDARS GmbH | |
| Berlin, Germany | |
| Pneumologisches Forschungsinstitut GmbH am Krankenhaus | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Minden, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| Neurologische Klinik der Otto-von-Guericke-Universität | |
| Magdeburg, Germany | |
| Pneumologisches Forschungsinstitut GmbH | |
| Großhansdorf, Germany | |
| ClinPharm International GmbH & Co. KG | |
| Leipzig, Germany | |
| Johannes-Gutenberg-Universität Mainz | |
| Mainz, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Hannover, Germany | |
| Medizinische Klinik III | |
| Moers, Germany | |
| Abt. Lungen- und Bronchialheilkunde | |
| Schmallenberg, Germany | |
| Italy | |
| U. O. di Pneumologia e Servizio di Fisiopatologia Resp. | |
| Milano, Italy | |
| U. O. di Pneumologia | |
| Trieste, Italy | |
| Dip. di Medicina Interna e Medicina Specialistica | |
| Catania, Italy | |
| Ospedale Generale Provinciale Mazzoni | |
| ASCOLI PICENO, Italy | |
| U. O. di Fisiopatologia Respiratoria | |
| Ferrara, Italy | |
| IRCCS Policlinico San Matteo | |
| PAVIA, Italy | |
| U. O. C di Pneumologia | |
| Roma, Italy | |
| Ospedale Silvestrini | |
| SAN SISTO (PG), Italy | |
| Ospedale S. Martino | |
| GENOVA, Italy | |
| South Africa | |
| UCT Lung Institute | |
| Cape Town, South Africa | |
| 1 Military Hospital | |
| Pretoria, South Africa | |
| Tygerberg Hospital | |
| Tygerberg, South Africa | |
| Hydromed Hospital | |
| Bloemfontein, South Africa | |
| Switzerland | |
| Universitätskliniken Basel | |
| Basel, Switzerland | |
| Ospedale Regionale | |
| Lugano, Switzerland | |
| Kantonsspital St. Gallen | |
| St. Gallen, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Laufen, Switzerland | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Davos, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Locarno, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Münchenstein, Switzerland | |
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
| Study ID Numbers: | 205.251 |
| Study First Received: | October 14, 2005 |
| Last Updated: | November 26, 2008 |
| ClinicalTrials.gov Identifier: | NCT00239473 |
| Health Authority: | United States: Food and Drug Administration |
|
Lung Diseases, Obstructive Ipratropium Respiratory Tract Diseases Bromides |
Lung Diseases Chronic Disease Tiotropium Pulmonary Disease, Chronic Obstructive |
|
Parasympatholytics Respiratory System Agents Disease Attributes Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Physiological Effects of Drugs Anti-Asthmatic Agents |
Cholinergic Agents Pharmacologic Actions Pathologic Processes Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |
