Efficacy and Safety of Tiotropium Inhalation Capsules and Atrovent MDI in Patients With Chronic Obstructive Pulmonary Disease (COPD)

You may be eligible if

• Inclusion:
• 1. COPD patients with an Forced Expiratory Volume in one second (FEV1)\<= 65% of predicted normal and FEV1 \<= 70% of Forced Vital Capacity (FVC).
• 2. Male or female patients 40 years of age or older.
• 3. Patients must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking one pack of cigarettes per day for a year.
• 4. Patients must be able to perform pulmonary function tests as required in the protocol.
• 5. Patients must be able to inhale medication from the HandiHaler device and should have a good technique of inhaling aerosol administered from an MDI..
• 6. All patients must sign an Informed Consent Form prior to participation in the trial i.e., prior to pre-study washout of their usual pulmonary medications.
• Exclusion:
• 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's ability to participate in the study.
• 2. Patients with clinically significant abnormal baseline hematology, blood chemistry or urinalysis, if the abnormality defines a disease listed as an exclusion criterion will be excluded.
• 3. All patients with a SGOT and SGPT twice the upper normal limit, bilirubin 150% or creatinine 125% of the upper normal limit will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects.
• 4. Patients with a recent history (i.e. one year or less) of myocardial infarction.
• 5. Any unstable or life threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
• 6. Patients with regular use of daytime oxygen therapy.
• 7. Patients with known active tuberculosis.
• 8. Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
• 9. Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis.
• 10. A history of thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per Exclusion 1.
• 11. Patients with an upper respiratory tract infection in the past 6 weeks prior to the Screening Visit (=Visit 1) or during the baseline period of 2-weeks (run-in period).
• 12. Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system.
• 13. Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction. (Patients on BPH medications with minimum symptoms are permitted).
• 14. Patients with known narrow-angle glaucoma.
• 15. Patients who are being treated with cromolyn sodium or nedocromil sodium.
• 16. Patients who are being treated with antihistamines.
• 17. Patients using oral corticosteroid medication at unstable dosage (i.e. less than 6 weeks on a stable dose) or at a dose in excess of the equivalent 10 mg of prednisone per day or 20 mg every other day.
• 18. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
• 19. Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count bigger or equal 400 per ul (males) or bigger/equal 320 per ul (females). A repeat eosinophil count will not be conducted in these patients.
• 20. Patients with a history and/or active alcohol or drug abuse.
• 21. Patients who have taken an investigational drug one month or six half-lives (whichever is greater) prior to the Screening Visit (=Visit 1).