Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.

Completed · Phase 2

Conditions studied: Pulmonary Disease, Chronic Obstructive, Asthma

In brief

The primary objective of this study is to determine the optimum dose(s) of BI 1744 CL inhalation solution delivered by the Respimat® inhaler for four weeks in patients with chronic obstructive pulmonary disease (COPD). The selection of the optimum dose(s) will be based on bronchodilator efficacy (how well it helps your breathing), safety evaluations and pharmacokinetic evaluations (the amount of the medication found in your blood).

Key facts

Study ID

NCT00452400

Run by

Boehringer Ingelheim

People needed

409

Starts

2007-03-01

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 sign an informed consent consistent with ICH-GCP guidelines prior to participation in the trial, which includes medication washout and restrictions
• 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
• 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. Patients who have never smoked cigarettes must be excluded
• 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
• Patients must be able to inhale medication in a competent manner from the Respimat® inhaler and from a metered dose inhaler (MDI).

You may not qualify if…

• Selection of relevant exclusion criteria:
• Patients with a history of asthma or a total blood eosinophil count 600/mm3.
• 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)
• 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
• Patients who have undergone thoracotomy with pulmonary resection
• 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
• 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
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
• Pregnant or nursing women
• Women of childbearing potential not using a highly effective method of birth control
• Patients who have previously been randomized in this study or are currently participating in another study
• Patients who are unable to comply with medication restrictions.

Where it is running

• 1222.5.03 Boehringer Ingelheim Investigational Site — Birmingham, Alabama, United States
• 1222.5.07 Boehringer Ingelheim Investigational Site — Lakewood, California, United States
• 1222.5.14 Boehringer Ingelheim Investigational Site — Denver, Colorado, United States
• 1222.5.13 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1222.5.17 Boehringer Ingelheim Investigational Site — Wheat Ridge, Colorado, United States
• 1222.5.18 Boehringer Ingelheim Investigational Site — Stamford, Connecticut, United States
• 1222.5.15 Boehringer Ingelheim Investigational Site — Panama City, Florida, United States
• 1222.5.04 Boehringer Ingelheim Investigational Site — Coeur d'Alene, Idaho, United States
• 1222.5.22 Boehringer Ingelheim Investigational Site — Shreveport, Louisiana, United States
• 1222.5.11 Boehringer Ingelheim Investigational Site — Reno, Nevada, United States
• 1222.5.24 Boehringer Ingelheim Investigational Site — New York, New York, United States
• 1222.5.12 Boehringer Ingelheim Investigational Site — Raleigh, North Carolina, United States
• 1222.5.10 Boehringer Ingelheim Investigational Site — Medford, Oregon, United States
• 1222.5.05 Boehringer Ingelheim Investigational Site — Hershey, Pennsylvania, United States
• 1222.5.02 Boehringer Ingelheim Investigational Site — Philadelphia, Pennsylvania, United States
• 1222.5.08 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1222.5.19 Boehringer Ingelheim Investigational Site — Charleston, South Carolina, United States
• 1222.5.06 Boehringer Ingelheim Investigational Site — Spartanburg, South Carolina, United States
• 1222.5.21 Boehringer Ingelheim Investigational Site — Kileen, Texas, United States
• 1222.5.01 Boehringer Ingelheim Investigational Site — San Antonio, Texas, United States
• 1222.5.23 Boehringer Ingelheim Investigational Site — Richmond, Virginia, United States
• 1222.5.20 Boehringer Ingelheim Investigational Site — Tacoma, Washington, United States
• 1222.5.039 St. Boniface General Hospital & Health Science Centre — Winnipeg, Manitoba, Canada
• 1222.5.032 Division of Respirology — Halifax, Nova Scotia, Canada
• 1222.5.038 Courtice Health Centre — Courtice, Ontario, Canada

Full record on ClinicalTrials.gov

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