Efficacy and Safety of Ba679BR Powder Inhalation in Patients With Chronic Obstructive Pulmonary Disease (COPD)

A Multiple Dose Comparison of 18 µg, 36 µg of Ba679BR (Tiotropium) Inhalation Capsules and Oxitropium Metered Dose Inhaler (2 Puffs of 100µg) in a 4-week, Double-Blind, Double-Dummy, Safety and Efficacy Study in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study to investigate the efficacy and safety of Ba679BR powder inhalation during the continuous once/day administration to the patients with COPD using oxitropium bromide (Tersigan® aerosol) as the comparator drug.

Inclusion Criteria:

Diagnosis of COPD (chronic bronchitis, and emphysema) with stable symptoms:

• Screening FEV1.0 ≤70% of predicted normal vale and screening FEV1.0/FVC ≤70% (the baseline FEV1.0 should also be ≤70% of predicted normal value on the initial day of administration)
• Smoking history ≥ 10 pack-years (a peak-year is 20 cigarettes per day for one year or equivalent)
• Male or female patients 40 years of age or older

Exclusion Criteria:

• History of bronchial asthma
• History of an atopic disease such as allergic rhinitis
• Total blood eosinophil count ≥ 600/µL
• Patient treated with antiallergic drugs or anti-histamine drugs
• Patients using oral corticosteroid medication at unstable doses (i.e. less than one month on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisolone per day
• Patients using inhaled steroid, oral β2 stimulant, theophylline preparation, expectorant or macrolide antibiotic at unstable doses (i.e. less than one month on a stable dose)
• Patients using an ACE inhibitor at unstable doses (i.e. less than one month on a stable dose)
• Patients with known narrow-angle glaucoma
• Patients with known symptomatic prostatic hypertrophy
• Patients with known hypersensitivity to anticholinergic drugs, lactose or any other components of the inhalation capsule delivery system
• Patients with significant diseases who in the opinion of the investigator were not eligible for the study
• Patients with clinically significant abnormal baseline laboratory test values (hematology, blood chemistry, urinalysis). Patients with serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamic-pyruvic transaminase (SGPT) twice the upper limit of the normal range, bilirubin 150% or creatinine 125% of the upper limit of the normal range were excluded
• Patients with a recent history (i.e. within the 3 months prior to the screening visit) of myocardial infarction or heart failure
• Patients with any cardiac arrhythmia requiring drug therapy
• Patients who were treated with Patients who were treated with β-blockers-blockers
• Patients with regular use of daytime oxygen therapy
• Patients with known active tuberculosis or with obvious sequela of tuberculosis
• Patients with a history of cancer within the last 5 years. Patients with treated basal cell carcinoma were allowed
• Patients with a history of cystic fibrosis or bronchiectasis
• Patients with upper respiratory tract infection in the past one month prior to the screening visit or during the baseline period
• Patients who had taken an investigational drug within one month or six half lives (whichever is greater) prior to the screening visit
• Pregnant or nursing women or women of childbearing potential
• Other than the above, patients who in the opinion of the investigator were not eligible for the study