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Efficacy and Safety of 4 Weeks Treatment With Inhaled BI 1744 CL in Patients With COPD.
This study has been completed.
Sponsored by: Boehringer Ingelheim Pharmaceuticals
Information provided by: Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00452400
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Asthma
Drug: BI 1744CL
Phase II

MedlinePlus related topics: Asthma COPD (Chronic Obstructive Pulmonary Disease)
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy and Safety of 4 Weeks of Treatment of Orally Inhaled BI 1744 CL (3 - 4 Doses) Delivered by the Respimat® Inhaler in Patients With COPD

Further study details as provided by Boehringer Ingelheim Pharmaceuticals:

Enrollment: 409
Study Start Date: March 2007
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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:

  1. Patients with a history of asthma or a total blood eosinophil count ³ 600/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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00452400

  Show 42 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim Pharmaceuticals
  More Information

Responsible Party: Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair )
Study ID Numbers: 1222.5
Study First Received: March 26, 2007
Last Updated: December 9, 2008
ClinicalTrials.gov Identifier: NCT00452400  
Health Authority: Canada: Therapeutic Products Directorate;   Germany: BfArM Bundesinstitut fuer Arzneimittel und Medizinprodukte;   Netherlands: Central Committee on Research Involving Human Subjects (CCMO);   United States: Food and Drug Administration

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Asthma
Chronic Disease
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009