A Multinational, Randomised, Double-blind, Placebo- and Active-controlled, Parallel Group Efficacy and Safety Comparison Over 24 Weeks of Three Doses (50µg, 100µg, 200µg) of BEA 2180 BR to Tiotropium 5µg, Delivered by the Respimat Inhaler and Placebo in Patients With Chronic Obstructive Pulmonary Disease (COPD)
- NCT00528996
- PHASE2
- INTERVENTIONAL
Last updated: 2021-08-24
Purpose of Trial
The primary objective of this study is to compare the bronchodilator efficacy of three doses (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives include comparing the effects on dyspnea and health status.
This study is for people with
Pulmonary Disease, Chronic Obstructive
Interventions being studied
BEA 2180 BR
Tiotropium Bromide
Placebo
Inclusion Criteria:
1. All patients must sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions.
2. All patients must have a diagnosis of chronic obstructive pulmonary disease (P95 4381) and must meet the following spirometric criteria:
Patients must have relatively stable, moderate to severe airway obstruction with an FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) \<80% of predicted normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).
3. Male or female patients 40 years of age or older.
4. Patients must be current or ex-smokers with a smoking history of more than 10 pack years. Patients who have never smoked cigarettes must be excluded.
5. Patients must be able to perform technically acceptable pulmonary function tests and electronic PEFR measurements, and must be able to maintain records (Patient Daily Diary) during the study period as required in the protocol.
6. Patients must be able to inhale medication in a competent manner from the Respimat® inhaler (Appendix I)
Exclusion Criteria:
1. Patients with significant diseases other than COPD will be excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient ability to participate in the study.
2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a significant disease as defined in exclusion criterion No. 1.
3. Patients with a recent history (one year or less) of myocardial infarction.
4. Patients with any unstable or life-threatening cardiac arrhythmia.
5. Patients who have been hospitalized for heart failure within the past 3 years.
6. Patients with a malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as defined in exclusion criteria No. 1.
8. Patients with known narrow-angle glaucoma.
9. Patients with asthma or a history of asthma.
10. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or clinically evident bronchiectasis.
11. Patients with known active tuberculosis.
12. Patients with a history of and/or active significant alcohol or drug abuse. See exclusion criterion No. 1.
ELIGIBILITY
Gender: ALL
Age: 40+
Healthy Volunteers: No
56 Locations
Jasper
1205.14.061 Boehringer Ingelheim Investigational Site
Alabama, United States
Mobile
1205.14.054 Boehringer Ingelheim Investigational Site
Alabama, United States
Berkeley
1205.14.042 Boehringer Ingelheim Investigational Site
California, United States
La Jolla
1205.14.017 Boehringer Ingelheim Investigational Site
California, United States
Lakewood
1205.14.022 Boehringer Ingelheim Investigational Site
California, United States
Riverside
1205.14.046 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1205.14.008 Boehringer Ingelheim Investigational Site
California, United States
San Diego
1205.14.047 Boehringer Ingelheim Investigational Site
California, United States
Sepulveda
1205.14.037 Boehringer Ingelheim Investigational Site
California, United States
Denver
1205.14.041 Boehringer Ingelheim Investigational Site
Colorado, United States
Fort Collins
1205.14.027 Boehringer Ingelheim Investigational Site
Colorado, United States
Wheat Ridge
1205.14.034 Boehringer Ingelheim Investigational Site
Colorado, United States
Stamford
1205.14.050 Boehringer Ingelheim Investigational Site
Connecticut, United States
Bay Pines
1205.14.013 Boehringer Ingelheim Investigational Site
Florida, United States
Clearwater
1205.14.016 Boehringer Ingelheim Investigational Site
Florida, United States
DeLand
1205.14.048 Boehringer Ingelheim Investigational Site
Florida, United States
Panama City
1205.14.043 Boehringer Ingelheim Investigational Site
Florida, United States
Tampa
1205.14.040 Boehringer Ingelheim Investigational Site
Florida, United States
Atlanta
1205.14.007 Boehringer Ingelheim Investigational Site
Georgia, United States
Stockbridge
1205.14.053 Boehringer Ingelheim Investigational Site
Georgia, United States
Coeur d'Alene
1205.14.014 Boehringer Ingelheim Investigational Site
Idaho, United States
Olathe
1205.14.035 Boehringer Ingelheim Investigational Site
Kansas, United States
New Orleans
1205.14.057 Boehringer Ingelheim Investigational Site
Louisiana, United States
Shreveport
1205.14.052 Boehringer Ingelheim Investigational Site
Louisiana, United States
Ann Arbor
1205.14.036 Boehringer Ingelheim Investigational Site
Michigan, United States
Livonia
1205.14.019 Boehringer Ingelheim Investigational Site
Michigan, United States
Chesterfield
1205.14.018 Boehringer Ingelheim Investigational Site
Missouri, United States
Saint Louis
1205.14.032 Boehringer Ingelheim Investigational Site
Missouri, United States
Reno
1205.14.033 Boehringer Ingelheim Investigational Site
Nevada, United States
Brick
1205.14.044 Boehringer Ingelheim Investigational Site
New Jersey, United States
Cherry Hill
1205.14.056 Boehringer Ingelheim Investigational Site
New Jersey, United States
Summit
1205.14.058 Boehringer Ingelheim Investigational Site
New Jersey, United States
Albuquerque
1205.14.010 Boehringer Ingelheim Investigational Site
New Mexico, United States
Larchmont
1205.14.062 Boehringer Ingelheim Investigational Site
New York, United States
Mineola
1205.14.028 Boehringer Ingelheim Investigational Site
New York, United States
New Hyde Park
1205.14.030 Boehringer Ingelheim Investigational Site
New York, United States
New York
1205.14.021 Boehringer Ingelheim Investigational Site
New York, United States
Toledo
1205.14.059 Boehringer Ingelheim Investigational Site
Ohio, United States
Oklahoma City
1205.14.012 Boehringer Ingelheim Investigational Site
Oklahoma, United States
Medford
1205.14.031 Boehringer Ingelheim Investigational Site
Oregon, United States
Philadelphia
1205.14.003 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Pittsburgh
1205.14.004 Boehringer Ingelheim Investigational Site
Pennsylvania, United States
Johnston
1205.14.005 Boehringer Ingelheim Investigational Site
Rhode Island, United States
Charleston
1205.14.029 Boehringer Ingelheim Investigational Site
South Carolina, United States
Greer
1205.14.055 Boehringer Ingelheim Investigational Site
South Carolina, United States
Spartanburg
1205.14.020 Boehringer Ingelheim Investigational Site
South Carolina, United States
Fort Worth
1205.14.045 Boehringer Ingelheim Investigational Site
Texas, United States
Houston
1205.14.025 Boehringer Ingelheim Investigational Site
Texas, United States
Killeen
1205.14.060 Boehringer Ingelheim Investigational Site
Texas, United States
San Antonio
1205.14.002 Boehringer Ingelheim Investigational Site
Texas, United States
Richmond
1205.14.023 Boehringer Ingelheim Investigational Site
Virginia, United States
Richmond
1205.14.024 Boehringer Ingelheim Investigational Site
Virginia, United States
Roanoke
1205.14.026 Boehringer Ingelheim Investigational Site
Virginia, United States
Spokane
1205.14.009 Boehringer Ingelheim Investigational Site
Washington, United States
Spokane
1205.14.039 Boehringer Ingelheim Investigational Site
Washington, United States
Morgantown
1205.14.001 Boehringer Ingelheim Investigational Site
West Virginia, 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