Dose Ranging Study of Ba 679 BR Inhalation Powder in Chronic Obstructive Pulmonary Disease (COPD) Patients

Inclusion criteria

• In a pulmonary function test of Screening Test II, FEV1.0 was less than 70% of predict normal and FEV1.0 was less than 70% of FVC.
• In the reversibility test of Screening Test II, FEV1.0 was improved by 10% or more at 1 hour after inhalation of 2 puffs of an anticholinergic agent (Tersigan ® Aerozol)
• History of smoking (< no. of cigarettes a day x no. of years of smoking > = 200 or more)
• 40 years of age or older
• Regardless of sex and the length of disease period

Exclusion criteria

• A history of bronchial asthma
• A history of atopic disease, such as allergic rhinitis
• Blood eosinophil of 440/µl or more
• Continuous use of steroid drugs (oral administration, inhalation or injection) at a dose equivalent to over 5 mg daily of prednisolone
• A history of respiratory infection, including virus infection within 1 month before study initiation
• Tuberculosis, lung cancer or a history of pneumonectomy
• Glaucoma
• Under treatment of benign prostatic hypertrophy
• Hypersensitivity to anticholinergic agents or sympathomimetics
• Difficulty in expectoration of sputum
• Serious heart disease, renal disease, hepatic disease, endocrine disease or metabolic disease
• Use of any β blockers
• A history of myocardial infarction within the past 1 year
• A history of heart failure, cor pulmonale or arrhythmia requiring medication within the past 3 years
• A history of drug abuse or alcoholism
• Treatment of psychotic disease
• Pregnancy, possible pregnancy or lactation
• A history of participation in any other clinical studies within the past 6 months
• Judgment by the investigator that the patient is ineligible for inclusion in the present study