12 / 48 Week Pivotal PFT vs PBO in COPD I

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). The safety of BI 1744 CL inhalation solution delivered through the Respimat inhaler will also be compared to placebo.

Key facts

Study ID

NCT00782210

Run by

Boehringer Ingelheim

People needed

625

Starts

2008-11-01

Last updated by the study team

2014-06-09

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

• 1222.11.1116 Boehringer Ingelheim Investigational Site — Berkeley, California, United States
• 1222.11.1121 Boehringer Ingelheim Investigational Site — Los Angeles, California, United States
• 1222.11.1111 Boehringer Ingelheim Investigational Site — Fort Collins, Colorado, United States
• 1222.11.1117 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1222.11.1110 Boehringer Ingelheim Investigational Site — DeLand, Florida, United States
• 1222.11.1106 Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• 1222.11.1108 Boehringer Ingelheim Investigational Site — Evansville, Indiana, United States
• 1222.11.1109 Boehringer Ingelheim Investigational Site — Bowling Green, Kentucky, United States
• 1222.11.1113 Boehringer Ingelheim Investigational Site — St Louis, Missouri, United States
• 1222.11.1115 Boehringer Ingelheim Investigational Site — Larchmont, New York, United States
• 1222.11.1120 Boehringer Ingelheim Investigational Site — Toledo, Ohio, United States
• 1222.11.1105 Boehringer Ingelheim Investigational Site — Oklahoma City, Oklahoma, United States
• 1222.11.1112 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1222.11.1119 Boehringer Ingelheim Investigational Site — Greer, South Carolina, United States
• 1222.11.1102 Boehringer Ingelheim Investigational Site — Union, South Carolina, United States
• 1222.11.1124 Boehringer Ingelheim Investigational Site — Killeen, Texas, United States
• 1222.11.1101 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1222.11.1103 Boehringer Ingelheim Investigational Site — Spokane, Washington, United States
• 1222.11.1114 Boehringer Ingelheim Investigational Site — Spokane, Washington, United States
• 1222.11.1123 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1222.11.1143 Boehringer Ingelheim Investigational Site — Concord, New South Wales, Australia
• 1222.11.1145 Boehringer Ingelheim Investigational Site — Glebe, New South Wales, Australia
• 1222.11.1144 Boehringer Ingelheim Investigational Site — Westmead, New South Wales, Australia
• 1222.11.1142 Boehringer Ingelheim Investigational Site — Toorak Gardens, South Australia, Australia
• 1222.11.1122 Boehringer Ingelheim Investigational Site — Jasper, Alabama, United States

Full record on ClinicalTrials.gov

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