Japan Long-term Safety for Tiotropium Plus Olodaterol

Inclusion criteria

• Diagnosis of chronic obstructive pulmonary disease.
• Relatively stable airway obstruction with post FEV1< 80% predicted normal and post FEV1/FVC <70%.
• Male or female Japanese patients, 40 years of age or older.
• Smoking history of more than 10 pack years.

Exclusion criteria

• Significant disease other than COPD
• Clinically relevant abnormal lab values.
• History of asthma.
• Diagnosis of thyrotoxicosis
• Diagnosis of paroxysmal tachycardia
• History of myocardial infarction within 1 year of screening visit
• Unstable or life-threatening cardiac arrhythmia.
• Hospitalization for heart failure within the past year.
• Known active tuberculosis.
• Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years
• History of life-threatening pulmonary obstruction.
• History of cystic fibrosis.
• Clinically evident bronchiectasis.
• History of significant alcohol or drug abuse.
• Thoracotomy with pulmonary resection
• Oral ß-adrenergics.
• Oral corticosteroid medication at unstable doses
• Regular use of daytime oxygen therapy for more than one hour per day
• Pulmonary rehabilitation program in the six weeks prior to the screening visit
• Investigational drug within one month or six half lives (whichever is greater) prior to screening visit
• Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA
• Pregnant or nursing women.
• Women of childbearing potential not using a highly effective method of birth control
• Patients who are unable to comply with pulmonary medication restrictions
• Patients with narrow-angle glaucoma or micturition disorder due to prostatic hyperplasia etc.