Safety and Efficacy of BI 1744 CL in Patients With Chronic Obstructive Pulmonary Disease II
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI 1744); Olodaterol (BI 1744); Formoterol; Placebo
Intervention description: Comparison of low and high doses on efficacy and safety in COPD patients; Comparison of low and high doses on efficacy and safety in COPD patients; Active comparator with Olodaterol (BI 1744) on safety and efficacy in COPD patients; Placebo devices for comparison with Olodaterol (BI 1744) on safety and efficacy in COPD patients
Intervention MeSH terms: Formoterol Fumarate; Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 937.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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 patients with COPD.
    

Eligibility criteria:

        Inclusion criteria:

          1. 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

          2. Male or female patients, 40 years of age or older

          3. Patients must be current or ex-smokers with a smoking history of more than 10 pack
             years:

        Exclusion criteria:

          1. 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

          2. Patients with a history of asthma and/or total blood eosinophil count greater than
             600/mm3

          3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute)

          4. 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

          5. Patients who have undergone thoracotomy with pulmonary resection

          6. 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.

          7. Patients who regularly use daytime oxygen therapy for more than one hour per day.

          8. 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

          9. Pregnant or nursing women

         10. Women of childbearing potential not using two effective methods of birth control (one
             barrier and one non-barrier).