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Dose Finding Study in COPD

NCT ID: NCT00122434

Last Updated: 2017-12-28

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

PHASE2

Total Enrollment

389 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Brief Summary

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The primary objective of this study is to determine the optimum dose of BEA 2180 BR inhalation solut ion delivered by the Respimat ? inhaler once daily for four weeks in patients with COPD.

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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BEA 2180 BR

Intervention Type DRUG

tiotropium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 \>=30% and \<= 60% of predicted normal and FEV1 \<=70% of FVC at the baseline PFTs at Visit 1 (at both timepoints). 2. All patients must have an increase in FEV1 of at least 12% from baseline (th e -10 minute measurement) 45 min after inhalation of 80 ?g Atrovent MDI. 3. Male or female patients 40 years of age or older. 4. Smoker or ex-smoker with a history of more than 10 pack years. 1\.

Exclusion Criteria

Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
Minimum Eligible Age

40 Years

Maximum Eligible Age

83 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:

Locations

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UAB Lung Health Center

Birmingham, Alabama, United States

Site Status

Vapahcs 111P

Palo Alto, California, United States

Site Status

Boehringer Ingelheim Investigational Site

San Diego, California, United States

Site Status

GLAHS Sepulveda

Sepulveda, California, United States

Site Status

Rehabilitation Clinical Trial Center

Torrance, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

Hospital for Special Care

New Britain, Connecticut, United States

Site Status

Bay Pines VA Medical Center

Bay Pines, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Pembroke Pines, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

LSUHSC - Shreveport

Shreveport, Louisiana, United States

Site Status

VAMC-Reno

Reno, Nevada, United States

Site Status

North Shore Universtiy Hospital

New Hyde Park, New York, United States

Site Status

SVMMC

Toledo, Ohio, United States

Site Status

Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Site Status

Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Site Status

Frank Sciurba

Pittsburgh, Pennsylvania, United States

Site Status

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

MUSC

Charleston, South Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Harker Heights, Texas, United States

Site Status

MEDVAMC

Houston, Texas, United States

Site Status

McGuire VA

Fredericksburg, Virginia, United States

Site Status

Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

CHU du Sart Tilman (B35)

Angleur, , Belgium

Site Status

A.Z. VUB

Brussels, , Belgium

Site Status

UZ Antwerpen

Edegem, , Belgium

Site Status

AZ Jan Palfijn

Ghent, , Belgium

Site Status

UZ Gent

Ghent, , Belgium

Site Status

Virga Jesseziekenhuis

Hasselt, , Belgium

Site Status

Clinique Reine Astrid

Malmedy, , Belgium

Site Status

Heilig Hartziekenhuis

Menen, , Belgium

Site Status

Sint-Elisabethziekenhuis

Turnhout, , Belgium

Site Status

Ziekenhuisgroep Twente

Almelo, , Netherlands

Site Status

Amphia Ziekenhuis

Breda, , Netherlands

Site Status

Tjongerschans Ziekenhuis

Heerenveen, , Netherlands

Site Status

Atrium Medisch Centrum

Heerlen, , Netherlands

Site Status

Ziekenhuisgroep Twente

Hengelo, , Netherlands

Site Status

Academisch Ziekenhuis Nijmegen St. Radbout

Nijmegen, , Netherlands

Site Status

Gelre Ziekenhuizen

Zutphen, , Netherlands

Site Status

Countries

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United States Belgium Netherlands

Related Links

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http://onlinelibrary.wiley.com/doi/10.1111/j.1440-1843.2012.02302.x/abstract

Related Info

Other Identifiers

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1205.4

Identifier Type: -

Identifier Source: org_study_id