Pharmacokinetic Study in Elderly Patients With Chronic Obstructive Bronchitis (COPD)

Exclusion Criteria

• •Patients with significant diseases other than COPD were excluded from participation in the trial. A significant disease was defined as a disease which in the opinion of the investigator may either have put the patient at risk because of participation in the trial or a disease which may have influenced the results of the trial or the patient's ability to participate in the trial;
• •Patients with clinically significant abnormal baseline haematology, blood chemistry or urinalysis, if the abnormality defined a disease listed as an exclusion criterion;
• •Patients with alanine transaminase (ALT/SGOT) \> 80 IU/L or aspartate transaminase (AST/SGPT) \> 80 IU/L, or bilirubin \> 2.0 mg/dL or creatinine \> 2.0 mg/dL were excluded from participation in the trial, regardless of the patient's clinical condition. Repeat laboratory evaluations were not conducted in these patients;
• •Patients with a recent history (i.e., one year or less) of myocardial infarction (MI);
• •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 regular use of daytime oxygen therapy;
• •Patients with known active tuberculosis;
• •Patients with a history of cancer within the last five years. However, patients with treated basal cell carcinoma are allowed to participate;
• •Patients with a history of life-threatening pulmonary obstruction, or a history of cystic fibrosis or bronchiectasis;
• •Patients who had undergone thoracotomy with pulmonary resection. Patients with a history of a thoracotomy for other reasons were evaluated as per exclusion criterion # 1;
• •Patients who had developed an upper respiratory tract infection in six weeks prior to the Screening Visit (Visit 1) or during the baseline period;
• •Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system;
• •Patients with known symptomatic prostatic hypertrophy or bladder neck obstruction;
• •Patients with known narrow-angle glaucoma;
• •Patients treated with cromolyn sodium or nedocromil sodium;
• •Patients treated with antihistamines (H1 receptor antagonists);
• •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);
• •Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e. oral contraceptives, intrauterine devices, diaphragm or Norplant®);
• •Patients with a history of asthma, allergic rhinitis or atopy or patients with a total blood eosinophil count ≥ 600/mm3. A repeat eosinophil count was not conducted in these patients;
• •Patients with history and/or active alcohol or drug abuse.
• •Patients who had taken an investigational drug within one month or six half lives (whichever was greater) prior to Screening Visit (Visit 1).