Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
Launched by BOEHRINGER INGELHEIM · Mar 26, 2007
Trial Information
Current as of May 07, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- 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 and must meet the following spirometric criteria:
- • Patients must have relatively stable, moderate to severe airway obstruction with a post-bronchodilator FEV1 \ 30% of predicted normal and \< 80% of predicted normal and a post-bronchodilator FEV1 / FVC \< 70% at Visit 1
- • 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 PEFR measurements, and must be able to maintain records (Patient Daily e-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 and from a metered dose inhaler (MDI).
- Exclusion Criteria:
- Selection of relevant exclusion criteria:
- • 1. Patients with a history of asthma or a total blood eosinophil count 600/mm3.
- 2. Patients with any of the following conditions:
- • a diagnosis of thyrotoxicosis
- • a diagnosis of paroxysmal tachycardia (\>100 beats per minute)
- • a marked baseline prolongation of QT/QTc interval (e.g. repeated demonstration of a QTc interval \> 450 ms).
- • a history of additional risk factors for Torsade de Pointes (TdP) (e.g. heart failure, hypokalemia, family history of Long QT Syndrome)
- 3. Patients with any of the following conditions:
- • a history of myocardial infarction within 1 year of screening visit (Visit 1)
- • a diagnosis of clinically relevant cardiac arrhythmia
- • 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
- • clinically evident bronchiectasis
- • a history of significant alcohol or drug abuse
- • 4. Patients who have undergone thoracotomy with pulmonary resection
- • 5. Patients who regularly use daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
- • 6. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the Screening Visit (Visit 1) or patients who are currently in a pulmonary rehabilitation program
- • 7. Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
- • 8. Pregnant or nursing women
- • 9. Women of childbearing potential not using a highly effective method of birth control
- • 10. Patients who have previously been randomized in this study or are currently participating in another study
- • 11. Patients who are unable to comply with medication restrictions.
About Boehringer Ingelheim
Boehringer Ingelheim is a global, research-driven pharmaceutical company dedicated to improving health and quality of life through innovative therapies. Established in 1885 and headquartered in Ingelheim, Germany, the company focuses on the development of prescription medicines in key therapeutic areas, including respiratory diseases, cardiovascular health, oncology, and immunology. Boehringer Ingelheim is committed to advancing medical science through rigorous clinical trials and collaborative research, striving to bring novel treatments to patients while upholding the highest standards of safety and efficacy. With a strong emphasis on sustainability and corporate responsibility, the company aims to make a meaningful impact on global health challenges.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Lakewood, California, United States
Denver, Colorado, United States
Wheat Ridge, Colorado, United States
Wheatridge, Colorado, United States
Stamford, Connecticut, United States
Panama City, Florida, United States
Coeur D'alene, Idaho, United States
Shreveport, Louisiana, United States
Reno, Nevada, United States
New York, New York, United States
Raleigh, North Carolina, United States
Medford, Oregon, United States
Hershey, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Spartanburg, South Carolina, United States
Kileen, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Tacoma, Washington, United States
Winnipeg, Manitoba, Canada
Halifax, Nova Scotia, Canada
Courtice, Ontario, Canada
Kingston, Ontario, Canada
Mississauga, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Sherbrooke, Quebec, Canada
Ste Foy, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Berlin, , Germany
Berlin, , Germany
Gauting, , Germany
Großhansdorf, , Germany
Rüdersdorf, , Germany
Wiesbaden, , Germany
Almelo, , Netherlands
Breda, , Netherlands
Eindhoven, , Netherlands
Heerlen, , Netherlands
Patients applied
Trial Officials
Boehringer Ingelheim
Study Chair
Boehringer Ingelheim
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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