A Randomized, Multiple-dose, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Study to Determine the Optimum Dose of BEA 2180 BR Delivered by the Respimat® Inhaler in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- NCT00122434
- PHASE2
- INTERVENTIONAL
Last updated: 2017-12-28
Purpose of Trial
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.
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
27 Locations
Birmingham
UAB Lung Health Center
Alabama, United States
Palo Alto
Vapahcs 111P
California, United States
San Diego
Boehringer Ingelheim Investigational Site
California, United States
Sepulveda
GLAHS Sepulveda
California, United States
Torrance
Rehabilitation Clinical Trial Center
California, United States
Wheat Ridge
Boehringer Ingelheim Investigational Site
Colorado, United States
New Britain
Hospital for Special Care
Connecticut, United States
Bay Pines
Bay Pines VA Medical Center
Florida, United States
Panama City
Boehringer Ingelheim Investigational Site
Florida, United States
Pembroke Pines
Boehringer Ingelheim Investigational Site
Florida, United States
Coeur d'Alene
Boehringer Ingelheim Investigational Site
Idaho, United States
Shreveport
LSUHSC - Shreveport
Louisiana, United States
Reno
VAMC-Reno
Nevada, United States
New Hyde Park
North Shore Universtiy Hospital
New York, United States
Toledo
SVMMC
Ohio, United States
Medford
Boehringer Ingelheim Investigational Site
Oregon, United States
Hershey
Hershey Medical Center
Pennsylvania, United States
Philadelphia
Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Pittsburgh
Frank Sciurba
Pennsylvania, United States
Charleston
Boehringer Ingelheim Investigational Site
South Carolina, United States
Charleston
MUSC
South Carolina, United States
Spartanburg
Boehringer Ingelheim Investigational Site
South Carolina, United States
Harker Heights
Boehringer Ingelheim Investigational Site
Texas, United States
Houston
MEDVAMC
Texas, United States
Fredericksburg
McGuire VA
Virginia, 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