Status:
COMPLETED
12 / 48 Week Pivotal PFT vs PBO in COPD I
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 :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
625 Patients enrolled
Trial Details
Trial ID
NCT00782210
Start Date
November 1 2008
Last Update
June 9 2014
Active Locations (54)
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1
1222.11.1122 Boehringer Ingelheim Investigational Site
Jasper, Alabama, United States
2
1222.11.1116 Boehringer Ingelheim Investigational Site
Berkeley, California, United States
3
1222.11.1121 Boehringer Ingelheim Investigational Site
Los Angeles, California, United States
4
1222.11.1111 Boehringer Ingelheim Investigational Site
Fort Collins, Colorado, United States