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Status:

COMPLETED

Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease I

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Pulmonary Disease, Chronic Obstructive

Eligibility:

All Genders

40+ years

Phase:

PHASE3

Brief Summary

The primary objective of this study is to assess the long-term efficacy and safety of once daily treatment of BI 1744 CL inhalation solution (5 and 10 mcg) delivered via the Respimat® inhaler, in pati...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • All patients must have a diagnosis of chronic obstructive pulmonary disease and must meet the following spirometric criteria:post-bronchodilator FEV1\<80% of predicted normal (ECSC) 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:
  • Exclusion criteria:
  • Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT \>x2 ULN, SGPT \>x2 ULN, bilirubin \>x2 ULN or creatinine \>x2 ULN
  • Patients with a history of asthma and/or total blood eosinophil count greater than 600/mm3
  • Patients with thyrotoxicosis, paroxysmal tachycardia (\>100 beats per minute)
  • Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization 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, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse
  • Patients who have undergone thoracotomy with pulmonary resection
  • Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
  • Patients who regularly use daytime oxygen therapy for more than one hour per day.
  • 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
  • Pregnant or nursing women
  • Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

Exclusion

    Key Trial Info

    Start Date :

    February 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    Estimated Enrollment :

    906 Patients enrolled

    Trial Details

    Trial ID

    NCT00793624

    Start Date

    February 1 2009

    Last Update

    June 27 2014

    Active Locations (93)

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    Page 1 of 24 (93 locations)

    1

    1222.13.2401 Boehringer Ingelheim Investigational Site

    Capital Federal, Argentina

    2

    1222.13.2403 Boehringer Ingelheim Investigational Site

    Capital Federal, Argentina

    3

    1222.13.2402 Boehringer Ingelheim Investigational Site

    Mar del Plata, Argentina

    4

    1222.13.2404 Boehringer Ingelheim Investigational Site

    Monte Grande, Argentina