BI 1744 CL With Respimat Once Daily Versus Twice Daily in COPD
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: BI 1744 CL
Intervention MeSH terms: Olodaterol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Crossover Assignment
Enrollment: 47.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of the trial is to determine the effect of BI 17444Cl on the lung
      function over a 24-hour period, when it is inhaled using the Respimat inhaler in patients
      with chronic obstructive pulmonary disease. In the trial four treatments of each 3 weeks of
      duration are included: 2 dosages in a once daily administration and 2 dosages for
      administration twice daily.
    

Eligibility 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 COPD and must meet the following spirometric
             criteria:

             Patients must have relatively stable airway obstruction with a post-bronchodilator
             FEV1 < 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

          5. Patients must be able to perform technically acceptable pulmonary function tests

          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 significant disease other than COPD.

          2. 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 will be excluded regardless of clinical condition.

          3. Patients with a history of asthma. For patients with allergic rhinitis or atopy,
             source documentation is required to verify that the patient does not have asthma. If a
             patient has a total blood eosinophil count more than 600/mm3, source documentation is
             required to verify that the increased eosinophil count is related to a non-asthmatic
             condition.

          4. Patients with any respiratory infection or COPD exacerbation in the 6 weeks prior to
             the Screening Visit (Visit 1) or during the baseline period.

          5. Patients with any of the following conditions: a diagnosis of thyrotoxicosis; a
             diagnosis of paroxysmal tachycardia (>100 beats per minute)

          6. Patients with any of the following conditions: a history of myocardial infarction
             within 1 year of screening visit (Visit 1); unstable or life-threatening cardiac
             arrhythmia; have been hospitalized 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 (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

          7. Patients who have undergone thoracotomy with pulmonary resection

          8. Patients being treated with any of the following concomitant medications: oral
             beta2-adrenergics; 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.

          9. Patients who regularly use daytime oxygen therapy for more than one hour per day.

         10. 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

         11. Patients who have taken an investigational drug within one month or six half lives
             (whichever is greater) prior to Screening Visit

         12. Patients with known hypersensitivity to beta-adrenergics drugs, BAC, EDTA or any other
             component of the Respimat inhalation solution delivery system

         13. Pregnant or nursing women

         14. Women of childbearing potential not using two effective methods of birth control (one
             barrier, one non-barrier). Female patients will be considered to be of childbearing
             potential unless surgically sterilised by hysterectomy or bilateral tubal ligation, or
             post-menopausal for at least two years

         15. Patients who have previously been randomized in this study or are currently
             participating in another study

         16. Patients who are unable to comply with pulmonary medication restrictions prior to
             randomization