Japan Long-term Safety for Tiotropium Plus Olodaterol
Japan Long-term Safety for Tiotropium Plus Olodaterol
The primary objective of this study is to assess the safety of 52 weeks once daily treatment
 with orally inhaled tiotropium + olodaterol FDC and olodaterol (delivered by the RESPIMAT
 Inhaler) in Japanese patients with Chronic Obstructive Pulmonary Disease (COPD).
Inclusion criteria:

 1. Diagnosis of chronic obstructive pulmonary disease.

 2. Relatively stable airway obstruction with post FEV1< 80% predicted normal and post
 FEV1/FVC <70%.

 3. Male or female Japanese patients, 40 years of age or older.

 4. Smoking history of more than 10 pack years.

 Exclusion criteria:

 1. Significant disease other than COPD

 2. Clinically relevant abnormal lab values.

 3. History of asthma.

 4. Diagnosis of thyrotoxicosis

 5. Diagnosis of paroxysmal tachycardia

 6. History of myocardial infarction within 1 year of screening visit

 7. Unstable or life-threatening cardiac arrhythmia.

 8. Hospitalization for heart failure within the past year.

 9. Known active tuberculosis.

 10. Malignancy for which patient has undergone resection, radiation therapy or
 chemotherapy within last five years

 11. History of life-threatening pulmonary obstruction.

 12. History of cystic fibrosis.

 13. Clinically evident bronchiectasis.

 14. History of significant alcohol or drug abuse.

 15. Thoracotomy with pulmonary resection

 16. Oral ß-adrenergics.

 17. Oral corticosteroid medication at unstable doses

 18. Regular use of daytime oxygen therapy for more than one hour per day

 19. Pulmonary rehabilitation program in the six weeks prior to the screening visit

 20. Investigational drug within one month or six half lives (whichever is greater) prior
 to screening visit

 21. Known hypersensitivity to ß-adrenergic drugs, anticholinergics, BAC, EDTA

 22. Pregnant or nursing women.

 23. Women of childbearing potential not using a highly effective method of birth control

 24. Patients who are unable to comply with pulmonary medication restrictions

 25. Patients with narrow-angle glaucoma or micturition disorder due to prostatic
 hyperplasia etc.