12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD
This study has been completed.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by:
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00239473
First received: October 14, 2005
Last updated: May 11, 2012
Last verified: May 2012
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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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- FEV1 (trough, AUC 0-6h; peak, onset and duration of response; percent responders), FVC (trough, AUC 0-6h, peak), twice daily PEFR, rescue medication use, COPD symptoms, global evaluations
Secondary Outcome Measures:
- Adverse events, vital signs, laboratory evaluations, ECG testing and physical examinations
| 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 |
Criteria
Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00239473
Locations
| Germany | |
| MEDARS GmbH | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Berlin, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Bonn, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Frankfurt/Main, Germany | |
| Inamed Research GmbH & Co. KG | |
| Gauting, Germany | |
| Pneumologisches Forschungsinstitut GmbH | |
| Großhansdorf, Germany | |
| Pneumologisches Forschungsinstitut GmbH am Krankenhaus | |
| Hamburg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Hannover, Germany | |
| Universitätsklinikum Schleswig-Holstein | |
| Kiel, Germany | |
| ClinPharm International GmbH & Co. KG | |
| Leipzig, Germany | |
| Neurologische Klinik der Otto-von-Guericke-Universität | |
| Magdeburg, Germany | |
| Johannes-Gutenberg-Universität Mainz | |
| Mainz, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Minden, Germany | |
| Medizinische Klinik III | |
| Moers, Germany | |
| Boehringer Ingelheim Investigational Site | |
| München, Germany | |
| Abt. Lungen- und Bronchialheilkunde | |
| Schmallenberg, Germany | |
| Boehringer Ingelheim Investigational Site | |
| Steinfurt, Germany | |
| Italy | |
| Ospedale Generale Provinciale Mazzoni | |
| Ascoli Piceno, Italy | |
| Dip. di Medicina Interna e Medicina Specialistica | |
| Catania, Italy | |
| U. O. di Fisiopatologia Respiratoria | |
| Ferrara, Italy | |
| Ospedale S. Martino | |
| Genova, Italy | |
| U. O. di Pneumologia e Servizio di Fisiopatologia Resp. | |
| Milano, Italy | |
| IRCCS Policlinico San Matteo | |
| Pavia, Italy | |
| U. O. C di Pneumologia | |
| Roma, Italy | |
| Ospedale Silvestrini | |
| San Sisto (pg), Italy | |
| U. O. di Pneumologia | |
| Trieste, Italy | |
| South Africa | |
| Hydromed Hospital | |
| Bloemfontein, South Africa | |
| UCT Lung Institute | |
| Cape Town, South Africa | |
| 1 Military Hospital | |
| Pretoria, South Africa | |
| Tygerberg Hospital | |
| Tygerberg, South Africa | |
| Switzerland | |
| Universitätskliniken Basel | |
| Basel, Switzerland | |
| Ospedale San Giovanni | |
| Bellinzona, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Davos, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Laufen, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Locarno, Switzerland | |
| Ospedale Regionale | |
| Lugano, Switzerland | |
| Boehringer Ingelheim Investigational Site | |
| Münchenstein, Switzerland | |
| Kantonsspital St. Gallen | |
| St. Gallen, Switzerland | |
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
| Study Chair: | Boehringer Ingelheim Study Coordinator | Boehringer Ingelheim Pharmaceuticals |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00239473 History of Changes |
| Other Study ID Numbers: | 205.251 |
| Study First Received: | October 14, 2005 |
| Last Updated: | May 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Ipratropium Tiotropium Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Parasympatholytics |
ClinicalTrials.gov processed this record on May 22, 2013