Comparison of Tiotropium Inhalation Capsules and Atrovent Metered Dose Inhaler (MDI) in a Efficacy and Safety Study in Adults With Chronic Obstructive Pulmonary Disease

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive Read More

Inclusion Criteria:

• COPD patients with an forced expiratory volume in one second (FEV1) <= 65% of predicted normal and FEV1 <= 70% of forced vital capacity (FVC)
• Male or female patients 40 years of age or older.
• Patient must have a smoking history of more than 10 pack-years. A pack-year is defined as the equivalent of smoking on pack of cigarettes per day for a year.
• Patient must be able to perform pulmonary function test as required in the protocol.
• Patient must be able to inhale medication from the handihaler device and should have a good technique of inhaling aerosol administered from MDI.
• All patients must sign an informed consent from prior to participation in the trail, prior to pre-study washout of their usual pulmonary medication.

Exclusion Criteria:

• Patient with significant disease 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 result of the study or the patient's ability to participate in the study.
• 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.
• All patients with a serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (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 be not be conducted in these subjects.
• Patients with a recent history ( i.e. one year or less) of myocardial infarction.
• Patients with a recent history ( i.e. one year or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy.
• Patients with regular use of daytime oxygen therapy.
• Patients with known active tuberculosis.
• Patients with a history of cancer within the last five years. Patients with treated basal cell carcinoma are allowed.
• Patients with a history of life-threatening pulmonary, or history of cystic fibrosis or bronchiectasis.
• Patients who have undergone pulmonary resection or a thoracotomy for any reason.
• Patients with an upper respiratory tract infection in the past 2 weeks prior to the screening visit (= Visit 1) or during the baseline period of 2-weeks (run-in period).
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule delivery system.
• Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction.
• Patients with known narrow-angle glaucoma.
• Patients who are being treated with cromolyn sodium or nedocromil sodium.
• Patients who are being treated with antihistamines.
• Patients using oral corticosteroid medication at unstable dosage (i.e. less than 6 weeks on a stable dose) or at a dose excess of the equivalent 10 mg of prednisone per day or 20 mg every day.
• Pregnant or nursing women or women of childbearing potential not using medically approved means of contraception (e.g. oral contraceptives, intrauterine devices, or diaphragm).
• Patients with a history of asthma, allergic rhinitis or atopy or who have a blood total eosinophil count >= 400 per microliter (males) or >= 320 per microliter (females). A repeat eosinophil count will not be conducted in these patients.
• Patients with a history and/or active alcohol or drug abuse.
• Patients who have taken an investigational drug on month or six half-lives (whichever is greater) prior to the screening visit (= Visit 1).