Efficacy and Safety of Tiotropium Compared to Salmeterol and Placebo in Patients With Chronic Obstructive Bronchitis (COPD)

Inclusion Criteria: * Age ≥ 40 years. * A diagnosis of relatively stable, moderate to severe COPD with: * Screening FEV1 ≤ 60% of predicted normal value (calculated according to European Community for Coal and Steel (ECCS) criteria and screening FEV1/FVC ≤ 70% * Smoking history ≥ 10 pack-years (a pack-year is 20 cigarettes per day for one year or equivalent) * Ability to be trained in the proper use of the HandiHaler® device and Metered Dose Inhaler (MDI). * Ability to perform all study related tests including the Shuttle Walking Test, acceptable pulmonary function tests, including Peak expiratory flow rate (PEFR) measurements, and maintenance of diary card records. * Ability to give written informed consent in accordance with Good Clinical Practice and local regulations. Exclusion Criteria: * Clinically significant diseases other than COPD. * Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion, will be excluded. * All patients with a serum glutamic oxaloacetic transaminase (SGOT) \> 80 IU/L, serum glutamic pyruvic transaminase (SGPT) \> 80 IU/L, bilirubin \>2.0 mg/dL or creatinine \> 2.0 mg/dL will be excluded regardless of clinical condition. * A recent history (i.e., one year or less) of myocardial infarction. * Any cardiac arrhythmia requiring drug therapy or hospitalisation for heart failure within the past three years. * Inability to abstain from regular daytime use of oxygen therapy for more than 1 hour per day. * Known active tuberculosis. * History of cancer within the last five years (excluding basal cell carcinoma) * History of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis. * Patients who have undergone thoracotomy with pulmonary resection. * Any upper respiratory infection in the past six weeks prior to the screening visit or during the run-in period. * Current participation in a pulmonary rehabilitation programme or completion of a pulmonary rehabilitation programme in the six week prior to the screening visit. * Known hypersensitivity to anticholinergic drugs, salmeterol, or any of the components of the lactose powder capsule or MDI delivery systems. * Known symptomatic prostatic hypertrophy or bladder neck obstruction. * Patients with known narrow-angle glaucoma. * Current treatment with cromolyn sodium or nedocromil sodium. * Current treatment with antihistamines (H1 receptor antagonists). * 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 prednisolone per day or 20 mg every other day. * Current use of β-blocker medication. * Current treatment with monoamine oxidase inhibitors or tricyclic antidepressants. * Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. * Patients with a history of asthma, allergic rhinitis or atopy or who have a total blood eosinophil count \> 600mm3. * History of and/or active significant alcohol or drug abuse. * Concomitant or recent use of an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit. * Changes in the pulmonary therapeutic plan within the six weeks prior to the screening visit. * Inability to comply with the medication restrictions specified in Section 4.2 of the trial protocol