Status:
COMPLETED
12 / 48 wk Pivotal PFT vs PBO in COPD II
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40+ years
Phase:
PHASE3
Brief Summary
This primary objective of this study is to compare two doses of BI 1744 CL inhalation solution delivered by the Respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- All patients must have a diagnosis of chronic obstructive pulmonary disease
- Male or female patients, 40 years of age or older Patients must be current or ex-smokers with a smoking history of more than 10 pack years Post bronchodilator FEV1 \<80% predicted and post-bronchodilator FEV1/FVC \<70%
- Exclusion criteria:
- Patients with a significant disease other than COPD
- Patients with a history of asthma
- Patients with any of the following conditions:
- a history of myocardial infarction within 1 year of screening visit (Visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
644 Patients enrolled
Trial Details
Trial ID
NCT00782509
Start Date
February 1 2009
Last Update
June 27 2014
Active Locations (51)
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1
1222.12.1227 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
2
1222.12.1218 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
3
1222.12.1226 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
4
1222.12.1214 Boehringer Ingelheim Investigational Site
Waterbury, Connecticut, United States