A Study to Characterize Pharmacokinetics of Tiotropium + Olodaterol Fixed-dose Combination in Japanese Patients With COPD.

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim
• Treatments: Olodaterol; Pharmaceutical Solutions; Tiotropium Bromide

Criteria

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