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12 Week Comparison of 5 Mcg and 10 Mcg of Tiotropium / Respimat, Placebo and Ipratropium MDI in COPD

NCT ID: NCT00239473

Last Updated: 2013-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

429 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Intervention Type DEVICE

10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhaler

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Principal Investigators

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Boehringer Ingelheim Study Coordinator

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

MEDARS GmbH

Berlin, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Bonn, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Frankfurt am Main, , Germany

Site Status

Inamed Research GmbH & Co. KG

Gauting, , Germany

Site Status

Pneumologisches Forschungsinstitut GmbH

Großhansdorf, , Germany

Site Status

Pneumologisches Forschungsinstitut GmbH am Krankenhaus

Hamburg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

Universitätsklinikum Schleswig-Holstein

Kiel, , Germany

Site Status

ClinPharm International GmbH & Co. KG

Leipzig, , Germany

Site Status

Neurologische Klinik der Otto-von-Guericke-Universität

Magdeburg, , Germany

Site Status

Johannes-Gutenberg-Universität Mainz

Mainz, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Minden, , Germany

Site Status

Medizinische Klinik III

Moers, , Germany

Site Status

Boehringer Ingelheim Investigational Site

München, , Germany

Site Status

Abt. Lungen- und Bronchialheilkunde

Schmallenberg, , Germany

Site Status

Boehringer Ingelheim Investigational Site

Steinfurt, , Germany

Site Status

Ospedale Generale Provinciale Mazzoni

Ascoli Piceno, , Italy

Site Status

Dip. di Medicina Interna e Medicina Specialistica

Catania, , Italy

Site Status

U. O. di Fisiopatologia Respiratoria

Ferrara, , Italy

Site Status

Ospedale S. Martino

Genova, , Italy

Site Status

U. O. di Pneumologia e Servizio di Fisiopatologia Resp.

Milan, , Italy

Site Status

IRCCS Policlinico San Matteo

Pavia, , Italy

Site Status

U. O. C di Pneumologia

Roma, , Italy

Site Status

Ospedale Silvestrini

San Sisto (pg), , Italy

Site Status

U. O. di Pneumologia

Trieste, , Italy

Site Status

Hydromed Hospital

Bloemfontein, , South Africa

Site Status

UCT Lung Institute

Cape Town, , South Africa

Site Status

1 Military Hospital

Pretoria, , South Africa

Site Status

Tygerberg Hospital

Tygerberg, , South Africa

Site Status

Universitätskliniken Basel

Basel, , Switzerland

Site Status

Ospedale San Giovanni

Bellinzona, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Davos, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Laufen, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Locarno, , Switzerland

Site Status

Ospedale Regionale

Lugano, , Switzerland

Site Status

Boehringer Ingelheim Investigational Site

Münchenstein, , Switzerland

Site Status

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status

Countries

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Germany Italy South Africa Switzerland

Other Identifiers

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205.251

Identifier Type: -

Identifier Source: org_study_id