Safety and Efficacy of Two Different Doses of Ipratropium Bromide Versus ATROVENT® Inhalation Aerosol in Adults With Chronic Obstructive Pulmonary Disease

Inclusion criteria

• All patients must have a diagnosis of COPD and must meet the following spirometric criteria:

• Patients must have relatively stable, moderate to severe airway obstruction with a FEV1 =< 65% of predicted normal and FEV1 =< 70% of FVC
• Male or female patients 40 years of age or older
• Patients must have a smoking history of more than ten packs-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year
• Patients must be able to perform pulmonary function tests and maintain records during the study period, as required in the protocol
• Patients must be able to be trained in the proper use of an inhalation aerosol and the Respimat device
• All patients must sign an Informed Consent Form prior to participation in the trial i.e., at least 24 hours prior to screening (Visit 1)

Exclusion criteria

• 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
• Patients with clinically relevant abnormal baseline haematology, blood chemistry or urinalysis. If the abnormality defines a disease listed as an exclusion criterion, the patient is excluded
• All patients with a serum glutamate oxaloacetate transaminase > 80 U/L, serum glutamate pyruvate transaminase > 80 U/L, bilirubin > 34.2 µmol/L or creatinine > 176.8 µmol/L will be excluded regardless of the clinical condition. Repeat laboratory evaluation will not be conducted in these subjects
• Patients who have a blood eosinophil count >= 0.6 GI/L. A repeat eosinophil count will not be conducted in these patients
• Patients with a recent history (i.e., one year or less) of myocardial infarction
• Patients with a recent history (i.e., three years or less) of heart failure or patients with any cardiac arrhythmia requiring drug therapy
• Patients with a history of cancer, other than treated basal cell carcinoma, within the last five years
• Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis
• Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons should be evaluated as per exclusion criterion #1
• Patients with a history of asthma, allergic rhinitis or atopy
• Patients with a history of and/or active alcohol or drug abuse
• Patients with known active tuberculosis
• Patients with an upper respiratory tract infection or COPD exacerbation in the past six weeks prior to the Screening Visit (Visit 1) or during the baseline period
• Patients with known symptomatic prostatic hypertrophy, bladder neck obstruction, or urinary retention
• Patients with known narrow-angle glaucoma, or raised intra-ocular pressure
• Patients with current significant psychiatric disorders
• Patients with regular use of daytime oxygen therapy
• 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 doses (i.e., less than six weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day
• Patients who are being treated with beta-blocker medication
• Patients who have had changes in their therapeutic plan within the last six weeks prior to the Screening Visit (Visit 1)
• Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®)
• Patients with known hypersensitivity to anticholinergic drugs or any other components of the ATROVENT® Solution including Benzalkonium chloride and Edetic acid
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to Screening Visit (Visit 1)
• Previous participation in this study