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

October 31, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
429

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Boehringer Ingelheim Investigational Site
      • Berlin, Germany
        • MEDARS GmbH
      • Bonn, Germany
        • Boehringer Ingelheim Investigational Site
      • Frankfurt/Main, Germany
        • Boehringer Ingelheim Investigational Site
      • Gauting, Germany
        • Inamed Research GmbH & Co. KG
      • Großhansdorf, Germany
        • Pneumologisches Forschungsinstitut GmbH
      • Hamburg, Germany
        • Pneumologisches Forschungsinstitut GmbH am Krankenhaus
      • Hannover, Germany
        • Boehringer Ingelheim Investigational Site
      • Kiel, Germany
        • Universitatsklinikum Schleswig-Holstein
      • Leipzig, Germany
        • ClinPharm International GmbH & Co. KG
      • Magdeburg, Germany
        • Neurologische Klinik der Otto-von-Guericke-Universität
      • Mainz, Germany
        • Johannes-Gutenberg-Universität Mainz
      • Minden, Germany
        • Boehringer Ingelheim Investigational Site
      • Moers, Germany
        • Medizinische Klinik Iii
      • München, Germany
        • Boehringer Ingelheim Investigational Site
      • Schmallenberg, Germany
        • Abt. Lungen- und Bronchialheilkunde
      • Steinfurt, Germany
        • Boehringer Ingelheim Investigational Site
  • Italy
      • Ascoli Piceno, Italy
        • Ospedale Generale Provinciale Mazzoni
      • Catania, Italy
        • Dip. di Medicina Interna e Medicina Specialistica
      • Ferrara, Italy
        • U. O. di Fisiopatologia Respiratoria
      • Genova, Italy
        • Ospedale S. Martino
      • Milano, Italy
        • U. O. di Pneumologia e Servizio di Fisiopatologia Resp.
      • Pavia, Italy
        • IRCCS Policlinico San Matteo
      • Roma, Italy
        • U. O. C di Pneumologia
      • San Sisto (pg), Italy
        • Ospedale Silvestrini
      • Trieste, Italy
        • U. O. di Pneumologia
  • South Africa
      • Bloemfontein, South Africa
        • Hydromed Hospital
      • Cape Town, South Africa
        • UCT Lung Institute
      • Pretoria, South Africa
        • 1 Military Hospital
      • Tygerberg, South Africa
        • Tygerberg Hospital
  • Switzerland
      • Basel, Switzerland
        • Universitätskliniken Basel
      • Bellinzona, Switzerland
        • Ospedale San Giovanni
      • Davos, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Laufen, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Locarno, Switzerland
        • Boehringer Ingelheim Investigational Site
      • Lugano, Switzerland
        • Ospedale Regionale
      • Münchenstein, Switzerland
        • Boehringer Ingelheim Investigational Site
      • St. Gallen, Switzerland
        • Kantonsspital St. Gallen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Trough FEV1 response
Time Frame: after 12 weeks
after 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Trough FEV1 response
Time Frame: after 1, 4 and 8 weeks
after 1, 4 and 8 weeks
Trough FVC response
Time Frame: after 1, 4, 8 and 12 weeks
after 1, 4, 8 and 12 weeks
FEV1 and FVC area under the curve (AUC)0-6h and peak response
Time Frame: after 0, 1, 4, 8 and 12 weeks
after 0, 1, 4, 8 and 12 weeks
Individual FEV1 and FVC measurements
Time Frame: during 12 weeks
during 12 weeks
Onset and duration of therapeutic response and percentage of responders
Time Frame: after 0 and 12 weeks
after 0 and 12 weeks
Weekly mean pre-dose morning and evening PEFR (peak expiratory flow rate)
Time Frame: up to 12 weeks
up to 12 weeks
Weekly mean number of occasions of rescue therapy used per day (PRN salbutamol)
Time Frame: up to 12 weeks
up to 12 weeks
COPD symptom scores (wheezing, shortness of breath, coughing and tightness of chest)
Time Frame: up to 15 weeks
up to 15 weeks
Physician's Global Evaluation
Time Frame: up to 15 weeks
up to 15 weeks
Number of patients with at least one exacerbation of COPD
Time Frame: up to 15 weeks
up to 15 weeks
Time to first exacerbation
Time Frame: up to 15 weeks
up to 15 weeks
Number of exacerbations and exacerbation days
Time Frame: up to 15 weeks
up to 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2002

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2003

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 31, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 205.251

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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