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High Dose Trial in COPD

NCT ID: NCT00128440

Last Updated: 2013-10-29

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

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Brief Summary

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The primary objective of this study was to compare the efficacy and safety of 200 μg and 400 μg of BEA 2180 BR to tiotropium 5 μg and placebo when each was 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

CROSSOVER

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

84 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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Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Site Status

Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

Boehringer Ingelheim Investigational Site

Pembroke Farms, Florida, United States

Site Status

Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Site Status

Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Site Status

Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

Boehringer Ingelheim Investigational Site

Harker Heights, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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1205.6

Identifier Type: -

Identifier Source: org_study_id