12 / 48 wk Pivotal PFT vs PBO in COPD II
Completed · Phase 3 · Has a placebo group
Conditions studied: Pulmonary Disease, Chronic Obstructive
In brief
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 disease (COPD).
Key facts
- Study ID
- NCT00782509
- Run by
- Boehringer Ingelheim
- People needed
- 644
- Starts
- 2009-02-01
- Last updated by the study team
- 2014-06-27
Who can join
Age: 40 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- 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
Where it is running
- 1222.12.1218 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
- 1222.12.1226 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
- 1222.12.1214 Boehringer Ingelheim Investigational Site — Waterbury, Connecticut, United States
- 1222.12.1207 Boehringer Ingelheim Investigational Site — Clearwater, Florida, United States
- 1222.12.1224 Boehringer Ingelheim Investigational Site — Panama City, Florida, United States
- 1222.12.1222 Boehringer Ingelheim Investigational Site — Tampa, Florida, United States
- 1222.12.1208 Boehringer Ingelheim Investigational Site — Winter Park, Florida, United States
- 1222.12.1220 Boehringer Ingelheim Investigational Site — River Forest, Illinois, United States
- 1222.12.1229 Boehringer Ingelheim Investigational Site — New Orleans, Louisiana, United States
- 1222.12.1219 Boehringer Ingelheim Investigational Site — Ann Arbor, Michigan, United States
- 1222.12.1209 Boehringer Ingelheim Investigational Site — Livonia, Michigan, United States
- 1222.12.1233 Boehringer Ingelheim Investigational Site — Henderson, Nevada, United States
- 1222.12.1228 Boehringer Ingelheim Investigational Site — Summit, New Jersey, United States
- 1222.12.1206 Boehringer Ingelheim Investigational Site — Albuquerque, New Mexico, United States
- 1222.12.1205 Boehringer Ingelheim Investigational Site — Rochester, New York, United States
- 1222.12.1213 Boehringer Ingelheim Investigational Site — Elizabeth City, North Carolina, United States
- 1222.12.1223 Boehringer Ingelheim Investigational Site — Harrisburg, North Carolina, United States
- 1222.12.1217 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
- 1222.12.1203 Boehringer Ingelheim Investigational Site — Cincinnatti, Ohio, United States
- 1222.12.1201 Boehringer Ingelheim Investigational Site — Pittsburgh, Pennsylvania, United States
- 1222.12.1230 Boehringer Ingelheim Investigational Site — Easley, South Carolina, United States
- 1222.12.1216 Boehringer Ingelheim Investigational Site — Greenville, South Carolina, United States
- 1222.12.1221 Boehringer Ingelheim Investigational Site — Dallas, Texas, United States
- 1222.12.1212 Boehringer Ingelheim Investigational Site — Danville, Virginia, United States
- 1222.12.1227 Boehringer Ingelheim Investigational Site — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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