Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomised, Double-Blind, Double-Dummy, Placebo- and Active-Controlled, Parallel Group Efficacy and Safety Comparison of 12-Week Treatment of Two Doses [5 μg (2 Actuations of 2.5 μg) and 10 μg (2 Actuations of 5 μg)] of Tiotropium Inhalation Solution Delivered by the Respimat Inhaler, Placebo and Ipratropium Bromide Inhalation Aerosol (MDI) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
| NCT number | NCT00239473 |
| Other study ID # | 205.251 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | October 14, 2005 |
| Last updated | October 31, 2013 |
| Start date | November 2002 |
| Verified date | October 2013 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 429 |
| Est. completion date | |
| Est. primary completion date | December 2003 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 40 Years and older |
| Eligibility | Outpatients of either sex, aged >/= 40 years with a diagnosis of COPD (FEV1 </= 60% predicted [ECCS criteria] and FEV1/FVC </= 70%) |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | MEDARS GmbH | 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 | |
| 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 | |
| South Africa | Hydromed Hospital | Bloemfontein | |
| South Africa | UCT Lung Institute | Cape Town | |
| South Africa | 1 Military Hospital | Pretoria | |
| South Africa | Tygerberg Hospital | Tygerberg | |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Germany, Italy, South Africa, Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Trough FEV1 response | after 12 weeks | No | |
| Secondary | Trough FEV1 response | after 1, 4 and 8 weeks | No | |
| Secondary | Trough FVC response | after 1, 4, 8 and 12 weeks | No | |
| Secondary | FEV1 and FVC area under the curve (AUC)0-6h and peak response | after 0, 1, 4, 8 and 12 weeks | No | |
| Secondary | Individual FEV1 and FVC measurements | during 12 weeks | No | |
| Secondary | Onset and duration of therapeutic response and percentage of responders | after 0 and 12 weeks | No | |
| Secondary | Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate) | up to 12 weeks | No | |
| Secondary | Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol) | up to 12 weeks | No | |
| Secondary | COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest) | up to 15 weeks | No | |
| Secondary | Physician's Global Evaluation | up to 15 weeks | No | |
| Secondary | Number of patients with at least one exacerbation of COPD | up to 15 weeks | No | |
| Secondary | Time to first exacerbation | up to 15 weeks | No | |
| Secondary | Number of exacerbations and exacerbation days | up to 15 weeks | No |
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