efficacy and safety of ba679br powder inhalation in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: 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.


Eligibility criteria:
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