A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.
The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol
 fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3
 weeks once daily treatment in Japanese patients with COPD.
Inclusion criteria:

 1. Diagnosis of chronic obstructive pulmonary disease

 2. Relatively stable airway obstruction with post FEV1=<30% of predicted normal and< 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. A marked baseline prolongation of QT/QTc interval

 7. A history of additional risk factors for Torsade de Pointes (TdP)

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

 9. Unstable or life-threatening cardiac arrhythmia

 10. Hospitalization for heart failure within the past year

 11. Known active tuberculosis

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

 13. History of life-threatening pulmonary obstruction

 14. History of cystic fibrosis

 15. Clinically evident bronchiectasis

 16. History of significant alcohol or drug abuse

 17. Thoracotomy with pulmonary resection

 18. Oral ß-adrenergics

 19. Oral corticosteroid medication at unstable doses

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

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

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

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

 24. Pregnant or nursing women

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

 26. Patients who have previously been randomized in this study or are currently
 participating in another study

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

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

 29. Patients being treated with medications that prolong the QT/QTc interval