An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: BEA 2180 BR; Tiotropium Bromide; Placebo
Intervention description: Solution; Solution; Solution
Intervention MeSH terms: Bromides; Tiotropium Bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2080.0
Sex: All
Minimum age: 40 Years
Maximum age: 100 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to compare the bronchodilator efficacy of three doses
      (50 µg, 100 µg and 200 µg) of BEA 2180 delivered by the Respimat® once daily to placebo and
      tiotropium bromide delivered by the Respimat® in patients with COPD. Additional objectives
      include comparing the effects on dyspnea and health status.
    

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 chronic obstructive pulmonary disease (P95 4381)
             and must meet the following spirometric criteria:

             Patients must have relatively stable, moderate to severe airway obstruction with an
             FEV1 (post-bronchodilator, 30 minutes post salbutamol/albuterol) <80% of predicted
             normal and FEV1 less than or equal to 70% of FVC at the PFTs at Visit 1 (screening).

          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
             electronic PEFR measurements, and must be able to maintain records (Patient Daily
             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 (Appendix I)

        Exclusion Criteria:

          1. Patients with significant diseases other than COPD will be excluded. A significant
             disease is defined as a disease which in the opinion of the investigator may either
             put the patient at risk because of participation in the study or a disease which may
             influence the results of the study or the patient ability to participate in the study.

          2. Patients with clinically relevant abnormal baseline haematology, blood chemistry or
             urinalysis, if the abnormality defines a significant disease as defined in exclusion
             criterion No. 1.

          3. Patients with a recent history (one year or less) of myocardial infarction.

          4. Patients with any unstable or life-threatening cardiac arrhythmia.

          5. Patients who have been hospitalized for heart failure within the past 3 years.

          6. Patients with a malignancy for which the patient has undergone resection, radiation
             therapy or chemotherapy within the last five years. Patients with treated basal cell
             carcinoma are allowed.

          7. Patients with known symptomatic prostatic hyperplasia or bladder neck obstruction as
             defined in exclusion criteria No. 1.

          8. Patients with known narrow-angle glaucoma.

          9. Patients with asthma or a history of asthma.

         10. Patients with a history of life-threatening pulmonary obstruction, or a history of
             cystic fibrosis or clinically evident bronchiectasis.

         11. Patients with known active tuberculosis.

         12. Patients with a history of and/or active significant alcohol or drug abuse. See
             exclusion criterion No. 1.