A Randomized, Multiple-dose, Double-Blind, Crossover Study to Compare the Efficacy and Safety of 200 μg and 400 μg of BEA 2180 BR to Tiotropium 5 μg and Placebo When Each is Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- NCT00128440
- PHASE2
- INTERVENTIONAL
Last updated: 2013-10-29
Purpose of Trial
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.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
BEA 2180 BR
tiotropium
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. Patients with any other significant disease will be excluded. 2. Patients with a history of asthma or allergic rhinitis will be excluded.
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
13 Locations
Lakewood
Boehringer Ingelheim Investigational Site
California, United States
Wheat Ridge
Boehringer Ingelheim Investigational Site
Colorado, United States
Pembroke Farms
Boehringer Ingelheim Investigational Site
Florida, United States
Coeur d'Alene
Boehringer Ingelheim Investigational Site
Idaho, United States
Reno
Boehringer Ingelheim Investigational Site
Nevada, United States
Larchmont
Boehringer Ingelheim Investigational Site
New York, United States
Winston-Salem
Boehringer Ingelheim Investigational Site
North Carolina, United States
Charleston
Boehringer Ingelheim Investigational Site
South Carolina, United States
Harker Heights
Boehringer Ingelheim Investigational Site
Texas, United States
Houston
Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
Boehringer Ingelheim Investigational Site
Texas, United States
Richmond
Boehringer Ingelheim Investigational Site
Virginia, United States
Tacoma
Boehringer Ingelheim Investigational Site
Washington, United States
Primary Contact(s)
Boehringer Ingelheim
Data obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Learn more at
ClinicalTrials.gov