Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry II
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: Olodaterol (BI 1744); Olodaterol (BI 1744); Placebo; Olodaterol (BI1744); Olodaterol (BI 1744) placebo
Intervention description: Comparison of low and high dose on exercise endurance time in COPD patients; Comparison of low and high dose on exercise endurance time in COPD patients; Comparison of low and high dose and placebo on exercise endurance time in COPD patients; Comparison of low and high dose on exercise endurance time in COPD patients; Placebo that represents olodaterol
Intervention MeSH terms: Olodaterol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Enrollment: 157.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of
      treatment in patients with Chronic Obstructive Pulmonary Disease.
    

Eligibility criteria:

        Inclusion criteria:

          1. Signed informed consent prior to participation.

          2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced
             Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator
             FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.

          3. Male or female between 40 and 75 years of age.

          4. Current or ex-smokers with smoking history of more than 10-pack years.

          5. Able to perform technically acceptable pulmonary function tests, multiple exercise
             tests and able to maintain records.

          6. Able to inhale medication in a competent manner from a metered-dose inhaler and
             Respimat inhaler.

        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 of 600
             cells/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 or contraindications to exercise.

          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 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 or patients who are currently in a pulmonary rehabilitation
             program.

          9. Patients who have a limitation of exercise performance as a result of factors other
             than fatigue or exertional dyspnea.

         10. Pregnant or nursing women.

         11. Women of childbearing potential not using two effective methods of birth control (one
             barrier and one non-barrier).