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Search / Trial NCT00452400

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 \&#61619; 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.

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

0 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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