NCT00239473

Brief Summary

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.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
429

participants targeted

Target at P50-P75 for phase_3

Geographic Reach
4 countries

38 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 17, 2005

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

October 14, 2005

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Trough FEV1 response

    after 12 weeks

Secondary Outcomes (12)

  • Trough FEV1 response

    after 1, 4 and 8 weeks

  • Trough FVC response

    after 1, 4, 8 and 12 weeks

  • FEV1 and FVC area under the curve (AUC)0-6h and peak response

    after 0, 1, 4, 8 and 12 weeks

  • Individual FEV1 and FVC measurements

    during 12 weeks

  • Onset and duration of therapeutic response and percentage of responders

    after 0 and 12 weeks

  • +7 more secondary outcomes

Interventions

5 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDEVICE
10 mcg once daily tiotropium inhalation solution delivered by the Respimat inhalerDEVICE

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Outpatients of either sex, aged \>/= 40 years with a diagnosis of COPD (FEV1 \</= 60% predicted \[ECCS criteria\] and FEV1/FVC \</= 70%)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (38)

Boehringer Ingelheim Investigational Site

Berlin, Germany

Location

MEDARS GmbH

Berlin, Germany

Location

Boehringer Ingelheim Investigational Site

Bonn, Germany

Location

Boehringer Ingelheim Investigational Site

Frankfurt am Main, Germany

Location

Inamed Research GmbH & Co. KG

Gauting, Germany

Location

Pneumologisches Forschungsinstitut GmbH

Großhansdorf, Germany

Location

Pneumologisches Forschungsinstitut GmbH am Krankenhaus

Hamburg, Germany

Location

Boehringer Ingelheim Investigational Site

Hanover, Germany

Location

Universitätsklinikum Schleswig-Holstein

Kiel, Germany

Location

ClinPharm International GmbH & Co. KG

Leipzig, Germany

Location

Neurologische Klinik der Otto-von-Guericke-Universität

Magdeburg, Germany

Location

Johannes-Gutenberg-Universität Mainz

Mainz, Germany

Location

Boehringer Ingelheim Investigational Site

Minden, Germany

Location

Medizinische Klinik III

Moers, Germany

Location

Boehringer Ingelheim Investigational Site

München, Germany

Location

Abt. Lungen- und Bronchialheilkunde

Schmallenberg, Germany

Location

Boehringer Ingelheim Investigational Site

Steinfurt, Germany

Location

Ospedale Generale Provinciale Mazzoni

Ascoli Piceno, Italy

Location

Dip. di Medicina Interna e Medicina Specialistica

Catania, Italy

Location

U. O. di Fisiopatologia Respiratoria

Ferrara, Italy

Location

Ospedale S. Martino

Genova, Italy

Location

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

Milan, Italy

Location

IRCCS Policlinico San Matteo

Pavia, Italy

Location

U. O. C di Pneumologia

Roma, Italy

Location

Ospedale Silvestrini

San Sisto (pg), Italy

Location

U. O. di Pneumologia

Trieste, Italy

Location

Hydromed Hospital

Bloemfontein, South Africa

Location

UCT Lung Institute

Cape Town, South Africa

Location

1 Military Hospital

Pretoria, South Africa

Location

Tygerberg Hospital

Tygerberg, South Africa

Location

Universitätskliniken Basel

Basel, Switzerland

Location

Ospedale San Giovanni

Bellinzona, Switzerland

Location

Boehringer Ingelheim Investigational Site

Davos, Switzerland

Location

Boehringer Ingelheim Investigational Site

Laufen, Switzerland

Location

Boehringer Ingelheim Investigational Site

Locarno, Switzerland

Location

Ospedale Regionale

Lugano, Switzerland

Location

Boehringer Ingelheim Investigational Site

Münchenstein, Switzerland

Location

Kantonsspital St. Gallen

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Boehringer Ingelheim Study Coordinator

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 17, 2005

Study Start

November 1, 2002

Primary Completion

December 1, 2003

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

IT(9)ZA(4)CH(8)DE(17)